Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT00754494
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2008-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timothy.morgan@va.gov', 'phone': '562-826-5756', 'title': 'Dr. Timothy R. Morgan', 'organization': 'University of California, Irvine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 15, 'otherNumAffected': 12, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': '80% DIMINISHED SEBORRHEIC KERATOSIS SKIN LESIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ALLERGIC REACTION: RASH ON THE FACE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BLOODY NOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BLUE COLORED URINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BLUE/GREEN COLORED URINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BLURRING OF VISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CANKER SORES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CLEARED UP ACNE ON MY FOREHEAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COLD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DEEP BRUISED LFT LEG PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "DIARRHEA-FREQUENT BM'S", 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY & ITCHY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY EYES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY ITCHY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY SKIN AROUND NOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY SKIN ON NOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY SKIN-(LEGS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRYNESS OF EYES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRYNESS OF SKIN ON FACE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DULL SORENESS IN LEG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'EARACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FACE PIMPLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FACE SORE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FLU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FOLLICULAR RASH ON TORSO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HEARTBURN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'INCARCERATED HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'IRRITABLE-MOOD ALTERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ITCHINESS OF EYES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'LIGHT HEADED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'LOOSE STOOLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'LOSS OF APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'LOTS OF GAS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'MILD DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'MILD INDIGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'MILD RASH IN THE BUTTOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'MOUTH SORES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NOSE BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN ON ABDOMEN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN ON FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PAINFUL ITCHY & TENDER SCALP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH ON CHEST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH ON FACE, CHEST AND SHOULDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH ON FACE, CHEST, AND BEHIND EARS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH ON FACE, SCALP AND CHEST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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{'term': 'RASH ON FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH ON FOREHEAD/NOSE/CHEST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RAW NOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RED ITCHY FACE RASH ON CHEEKS & NOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RED PUFFY EYES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RED RASH-FACE PEELING & NOW WHITE HEAD PIMPLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RED RASH-FACE,NOSE, & CHEST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RED RASH-FACE-NECK-CHEST & SCALP-ITCHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RED,BUMPY FACE 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'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SHORT OF BREATH EASILY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SHORT OF BREATH-DYSPNEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SHOULDER PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SORE THROAT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SWOLLEN FACE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SWOLLEN LEFT KNEE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ULCER ON MUCOUS MEMBRANE IN MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMIT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in ACF pERK Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: 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Tested using paired t-test with a two-sided significance level of 0.05.', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in ACF pERK levels not reported as the assay did not demonstrate signaling'}, {'type': 'SECONDARY', 'title': 'Change in EGF-inducible Markers - pEGFR in Normal Mucosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '2.58'}, {'value': '1.65', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '3.10'}, {'value': '0.97', 'groupId': 'OG002', 'lowerLimit': '0.68', 'upperLimit': '1.38'}]}]}], 'analyses': [{'pValue': '0.762', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.125', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.855', 'groupIds': ['OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'unitOfMeasure': 'expression level', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data is reported based on the evaluable samples collected and available results.'}, {'type': 'SECONDARY', 'title': 'Change in EGF-inducible Markers - Total EGFR in Normal Mucosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '9.40'}, {'value': '1.91', 'groupId': 'OG001', 'lowerLimit': '0.91', 'upperLimit': '4.00'}, {'value': '1.23', 'groupId': 'OG002', 'lowerLimit': '0.88', 'upperLimit': '1.72'}]}]}], 'analyses': [{'pValue': '0.369', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.085', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.233', 'groupIds': ['OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'unitOfMeasure': 'expression level', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data is reported based on the evaluable samples collected and available results.'}, {'type': 'SECONDARY', 'title': 'Change in EGF-inducible Markers - pEGFR in ACF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '2.48'}, {'value': '1.93', 'groupId': 'OG001', 'lowerLimit': '1.07', 'upperLimit': '3.48'}, {'value': '1.40', 'groupId': 'OG002', 'lowerLimit': '0.78', 'upperLimit': '2.53'}]}]}], 'analyses': [{'pValue': '0.651', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.261', 'groupIds': ['OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'unitOfMeasure': 'expression level', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data is reported based on the evaluable samples collected and available results.'}, {'type': 'SECONDARY', 'title': 'Change in EGF-inducible Markers - Total EGFR in ACF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '4.61'}, {'value': '2.22', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '4.54'}, {'value': '1.94', 'groupId': 'OG002', 'lowerLimit': '0.92', 'upperLimit': '4.09'}]}]}], 'analyses': [{'pValue': '0.654', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.083', 'groupIds': ['OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.', 'unitOfMeasure': 'expression level', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data is reported based on the evaluable samples collected and available results.'}, {'type': 'SECONDARY', 'title': 'ACF: Normal Mucosa pERK Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'timeFrame': 'Up to day 30', 'description': 'Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.', 'reportingStatus': 'POSTED', 'populationDescription': 'ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels'}, {'type': 'SECONDARY', 'title': 'Plasma Erlotinib Concentration (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'categories': [{'measurements': [{'value': '232.29', 'spread': '160.6', 'groupId': 'OG000'}, {'value': '486.56', 'spread': '211.8', 'groupId': 'OG001'}, {'value': '1280.84', 'spread': '788.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 30', 'description': 'Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data is reported based on the evaluable samples collected and available results.'}, {'type': 'SECONDARY', 'title': 'Plasma OSI-420 Concentration (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'categories': [{'measurements': [{'value': '17.77', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '33.87', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '117.98', 'spread': '84.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 30', 'description': 'Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data is reported based on the evaluable samples collected and available results.'}, {'type': 'SECONDARY', 'title': 'Normal Mucosa Erlotinib Concentration (ng/mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '3.25', 'spread': '4.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 30', 'description': 'Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data is reported based on the evaluable samples collected and available results.'}, {'type': 'SECONDARY', 'title': 'Normal Mucosa OSI-420 Concentration (ng/mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 30', 'description': 'Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data is reported based on the evaluable samples collected and available results.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reported at Least 1 Side Effect During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'title': 'At least 1 adverse event reported', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'No adverse event reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'description': 'Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reported at Least 1 Rash Side Effect During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'title': 'At least 1 rash AE reported', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'No rash AE reported', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'description': 'Described for each arm using frequencies.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 10 to 29 days'}, {'id': 'OG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 8 to 28 days'}, {'id': 'OG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nThe range of days on treatment is 7 to 23 days'}], 'classes': [{'title': 'At least 1 diarrhea AE reported', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'No diarrhea AE reported', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'description': 'Described for each arm using frequencies.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'FG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'FG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG001', 'title': 'Arm II (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG002', 'title': 'Arm III (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nerlotinib hydrochloride: Given PO\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.67', 'spread': '4.43', 'groupId': 'BG000'}, {'value': '62.47', 'spread': '6.03', 'groupId': 'BG001'}, {'value': '60.67', 'spread': '7.42', 'groupId': 'BG002'}, {'value': '62.27', 'spread': '6.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-22', 'studyFirstSubmitDate': '2008-09-17', 'resultsFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2008-09-17', 'lastUpdatePostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-22', 'studyFirstPostDateStruct': {'date': '2008-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ACF pERK Levels', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.'}], 'secondaryOutcomes': [{'measure': 'Change in EGF-inducible Markers - pEGFR in Normal Mucosa', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.'}, {'measure': 'Change in EGF-inducible Markers - Total EGFR in Normal Mucosa', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.'}, {'measure': 'Change in EGF-inducible Markers - pEGFR in ACF', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.'}, {'measure': 'Change in EGF-inducible Markers - Total EGFR in ACF', 'timeFrame': 'From baseline to post-treatment (up to 30 days)', 'description': 'Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.'}, {'measure': 'ACF: Normal Mucosa pERK Ratio', 'timeFrame': 'Up to day 30', 'description': 'Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.'}, {'measure': 'Plasma Erlotinib Concentration (ng/mL)', 'timeFrame': 'Up to day 30', 'description': 'Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).'}, {'measure': 'Plasma OSI-420 Concentration (ng/mL)', 'timeFrame': 'Up to day 30', 'description': 'Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).'}, {'measure': 'Normal Mucosa Erlotinib Concentration (ng/mg)', 'timeFrame': 'Up to day 30', 'description': 'Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).'}, {'measure': 'Normal Mucosa OSI-420 Concentration (ng/mg)', 'timeFrame': 'Up to day 30', 'description': 'Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).'}, {'measure': 'Number of Participants Reported at Least 1 Side Effect During the Study', 'timeFrame': 'Up to 9 weeks', 'description': 'Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.'}, {'measure': 'Number of Participants Reported at Least 1 Rash Side Effect During the Study', 'timeFrame': 'Up to 9 weeks', 'description': 'Described for each arm using frequencies.'}, {'measure': 'Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study', 'timeFrame': 'Up to 9 weeks', 'description': 'Described for each arm using frequencies.'}]}, 'conditionsModule': {'conditions': ['Adenomatous Polyp', 'Recurrent Colon Cancer', 'Recurrent Rectal Cancer', 'Stage I Colon Cancer', 'Stage I Rectal Cancer', 'Stage IIA Colon Cancer', 'Stage IIA Rectal Cancer', 'Stage IIB Colon Cancer', 'Stage IIB Rectal Cancer', 'Stage IIC Colon Cancer', 'Stage IIC Rectal Cancer', 'Stage IIIA Colon Cancer', 'Stage IIIA Rectal Cancer', 'Stage IIIB Colon Cancer', 'Stage IIIB Rectal Cancer', 'Stage IIIC Colon Cancer', 'Stage IIIC Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial is studying how well erlotinib hydrochloride works in treating patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming back', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To test the hypothesis that erlotinib (erlotinib hydrochloride) doses as low as 25 mg will decrease aberrant crypt foci (ACF) phosphorylated extracellular signal-regulated kinases (pERK) levels from baseline (pre) to post erlotinib treatment.\n\nSECONDARY OBJECTIVES:\n\nI. To test the hypothesis that additional epidermal growth factor (EGF) inducible biomarkers will decrease from baseline (pre) to post treatment with erlotinib 25 mg, 50 mg or 100 mg orally (PO) once daily (QD) therapy.\n\nII. To determine the mean decrease from baseline of the ACF: normal mucosa pERK ratio pre and post 8-30 days of erlotinib.\n\nIII. To determine erlotinib concentration in plasma and colorectal tissue at 25 mg, 50 mg and 100 mg doses after 8-30 days of therapy.\n\nIV. To determine the incidence of rash, diarrhea and other side effects of low dose erlotinib.\n\nOUTLINE: Patients are randomized to 1 of 3 treatment arms.\n\nARM I: Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.\n\nARM II: Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.\n\nARM III: Patients receive 25 mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.\n\nIn all arms, treatment continues for 8-30 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up for 4 to 9 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants with one or more of the following criteria will be eligible to participate:\n\n * History of Stage I-III colorectal cancer, not treated in the past 6 months with no anticipated treatment in the next 3 months\n * Adenoma ≥ 1 cm in size\n * 3 or more adenomas (of any size) removed at one colonoscopy within past 6 years\n * Sessile serrated adenoma ≥ 5 mm in size\n * Adenoma (of any size) with villous features (villous, tubulovillous)\n * Adenoma (of any size) with high grade dysplasia\n* Participants are eligible for randomization into the treatment phase of the trial if they are found to have ≥ 4 ACFs at either baseline colonoscopy or baseline flexible sigmoidoscopy\n* Blood tests at screening which meet the following criteria:\n* WBC \\> 3000/mm\\^3\n* Platelets \\> 100,000/mm\\^3\n* Hemoglobin \\> 10g/dl\n* Plasma creatinine of \\< 1.6mg/dl\n* Total bilirubin \\< 1.5 x the upper limit of normal\n* Serum ALT \\< 1.5 x the upper limit of normal\n* Serum AST \\< 1.5 x the upper limit of normal\n* ECOG performance status 0-1\n* Women of child-bearing potential and men taking study drug must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation\n* Ability to understand, as well as sign the written informed consent document\n* If a woman is of child-bearing potential, she must have a negative pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n\nExclusion Criteria:\n\n* History of Inflammatory Bowel Disease (IBD)\n* History of interstitial lung disease or chronic lung disease\n* Smoking within the past 3 months\n* Increased bleeding risk from rectal biopsy (Patients receiving aspirin or plavix can be enrolled)\n* Patients receiving warfarin or coumadin\n* Uncontrollable diarrhea of any cause\n* Patients, including rectal cancer patients, that have received prior radiation to the rectum or pelvis\n* Participants taking a known significant CYP 3A4 inducer or inhibitor; known significant inducers/inhibitors include: amprenavir, aprepitant, atazanavir, carbamazepine, clarithromycin, conivaptan, diltiazem, darunavir/ritonavir, dronedarone, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenytoin, posaconazole, rifampin, ritonavir, St. John's wort, saquinavir, telithromycin, tipranavir/ritonavir, verapamil, voriconazole\n* Women who are pregnant or breast-feeding\n* Active keratoconjunctivitis, or corneal surgery in the past three weeks\n* Any medical or psychosocial condition that could jeopardize the subject's participation in and compliance to the study\n* Participants who are taking any other investigational pharmaceutical agents\n* Previous history of sensitivity to erlotinib, Iressa, or Erbitux, such as a rash that is uncontrollable by topical steroids and/or antibiotics"}, 'identificationModule': {'nctId': 'NCT00754494', 'briefTitle': 'Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase IIa Randomized, Double-Blind Trial of Erlotinib in Inhibiting EGF Receptor Signaling in Aberrant Crypt Foci of the Colon', 'orgStudyIdInfo': {'id': 'NCI-2012-02984'}, 'secondaryIdInfos': [{'id': 'UCI06-8-01'}, {'id': 'N01CN35160', 'link': 'https://reporter.nih.gov/quickSearch/N01CN35160', 'type': 'NIH'}, {'id': 'CDR0000614277', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erlotinib Hydrochloride (25 mg)', 'description': 'Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.', 'interventionNames': ['Drug: erlotinib hydrochloride', 'Other: placebo', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Erlotinib Hydrochloride (50 mg)', 'description': 'Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.', 'interventionNames': ['Drug: erlotinib hydrochloride', 'Other: placebo', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Erlotinib Hydrochloride (100 mg)', 'description': 'Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.', 'interventionNames': ['Drug: erlotinib hydrochloride', 'Other: placebo', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'erlotinib hydrochloride', 'type': 'DRUG', 'otherNames': ['CP-358,774', 'erlotinib', 'OSI-774'], 'description': 'Given PO', 'armGroupLabels': ['Erlotinib Hydrochloride (100 mg)', 'Erlotinib Hydrochloride (25 mg)', 'Erlotinib Hydrochloride (50 mg)']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given PO', 'armGroupLabels': ['Erlotinib Hydrochloride (100 mg)', 'Erlotinib Hydrochloride (25 mg)', 'Erlotinib Hydrochloride (50 mg)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Erlotinib Hydrochloride (100 mg)', 'Erlotinib Hydrochloride (25 mg)', 'Erlotinib Hydrochloride (50 mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Timothy Morgan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chao Family Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}