Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT00275132
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2006-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 670}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2006-01-10', 'studyFirstSubmitQcDate': '2006-01-10', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'between date of randomisation and date of death from any cause'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'from the date of randomisation to the date of first clinical evidence of progressive disease, or death.'}, {'measure': 'Adverse events/Toxicity', 'timeFrame': 'during and for 28 days following Tarceva/placebo treatment'}, {'measure': 'Quality of life', 'timeFrame': 'between randomisation and 8 weeks.', 'description': 'QL will be measured using the patient-completed EORTC-QLQ C30 and lung cancer module (LC 14). The primary QL outcome measures will be changes in overall QL and the five most commonly reported lung cancer symptoms (fatigue, breathlessness, cough, emotional functioning and pain).'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'from date of randomisation to death', 'description': 'Effectiveness will be estimated in terms of quality-adjusted life years. Mean survival will be calculated on the basis of observed mortality (i.e. a within-trial estimate) and by extrapolating the survival curves if some patients remain alive at the end of the trial.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.\n\nPURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.\n\nSecondary\n\n* Compare progression-free survival and response rate.\n* Compare toxicity.\n* Compare the quality of life.\n* Compare cost-effectiveness.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral erlotinib once daily for up to 24 months.\n* Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.\n\nAfter completion of study treatment, patients are followed periodically for survival.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer\n\n * Advanced disease (stage IIIB or IV)\n * Diagnosis within 62 days prior to randomization\n* Not suitable for first-line chemotherapy, as defined by the following criteria\\*:\n\n * ECOG performance status 2-3\n * ECOG performance status 0-1 AND creatinine clearance \\< 60 mL/min\n* NOTE: \\*These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis\n* No symptomatic brain metastases\n\nPATIENT CHARACTERISTICS:\n\n* Estimated life expectancy of at least 8 weeks\n* Able to take oral medication\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No severe uncontrolled infection\n* No unstable angina\n* No myocardial infarction within the past month\n* No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)\n* No acute renal failure\n* Bilirubin \\< 2 times upper limit of normal (ULN)\n* Transaminases \\< 2 times ULN (5 times ULN if liver metastases are present)\n* Creatinine \\< 5 times ULN\n* No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications\n* No other prior or current malignant disease likely to interfere with study treatment or comparisons\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy\n* No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab)\n* No prior palliative radiotherapy\n\n * Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks\n* No concurrent cyclooxygenase-2 inhibitors"}, 'identificationModule': {'nctId': 'NCT00275132', 'acronym': 'TOPICAL', 'briefTitle': 'Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy', 'orgStudyIdInfo': {'id': 'CDR0000457755'}, 'secondaryIdInfos': [{'id': 'LLCG-TOPICAL'}, {'id': 'EU-20313'}, {'id': 'ISRCTN', 'type': 'REGISTRY', 'domain': '77383050'}, {'id': 'Cancer Research UK (CTAAC)', 'type': 'OTHER_GRANT', 'domain': 'C1438/A4147'}, {'id': 'Roche AG Pharma', 'type': 'OTHER_GRANT', 'domain': 'MO17591'}, {'id': 'UCL Trial Sponsor reference', 'type': 'OTHER', 'domain': 'UCL/05/173'}, {'id': 'EudraCT number', 'type': 'OTHER', 'domain': '2004-000729-31'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erlotinib', 'description': 'Tarceva (OSI-774, erlotinib) PO 150mg daily', 'interventionNames': ['Drug: erlotinib hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matched placebo', 'description': 'Matched placebo PO daily', 'interventionNames': ['Drug: Matched placebo']}], 'interventions': [{'name': 'erlotinib hydrochloride', 'type': 'DRUG', 'otherNames': ['OSI-774', 'Tarceva'], 'description': 'Tarceva (OSI-774, erlotinib) PO 150 mg daily', 'armGroupLabels': ['Erlotinib']}, {'name': 'Matched placebo', 'type': 'DRUG', 'description': 'Matched placebo PO daily', 'armGroupLabels': ['Matched placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 2ND', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'London Lung Cancer Group', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Siow M Lee, MD, PhD, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'University College London Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}, {'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}