Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-04 @ 1:15 PM
Study NCT ID:
NCT00887159
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2009-04-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'C557414', 'term': 'cixutumumab'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'C538724', 'term': 'HhAntag691'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '617-632-6012', 'title': 'Study statistician', 'organization': 'ECOG-ACRIN Statistical Office'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Assessed every 3 weeks while on treatment and for 30 days after the end of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A (CE)', 'description': 'Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 53, 'otherNumAffected': 52, 'seriousNumAtRisk': 53, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'Arm B (CE+GDC-0449)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 53, 'otherNumAffected': 52, 'seriousNumAtRisk': 53, 'seriousNumAffected': 44}, {'id': 'EG002', 'title': 'Arm C (CE+IMC-A12)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 52, 'otherNumAffected': 51, 'seriousNumAtRisk': 52, 'seriousNumAffected': 47}], 'otherEvents': [{'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 40}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Mucosal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Investigations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Metabolism and nutrition - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Musculoskeletal and connective - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal 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'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Musculoskeletal and connective - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Acoustic nerve disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (CE)', 'description': 'Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (CE+GDC-0449)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (CE+IMC-A12)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '5.5'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '5.4'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.47', 'pValueComment': 'P-value is one-sided.', 'estimateComment': 'The hazard ratio was derived comparing Arm B to Arm A.', 'groupDescription': 'There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.48', 'pValueComment': 'P-value is one-sided.', 'estimateComment': 'Hazard ratio was derived comparing Arm C to Arm A.', 'groupDescription': 'There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry', 'description': 'Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated patients.'}, {'type': 'SECONDARY', 'title': 'Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (CE)', 'description': 'Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (CE+GDC-0449)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (CE+IMC-A12)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '0.63'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.70'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '0.36', 'upperLimit': '0.64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry', 'description': 'Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).', 'unitOfMeasure': 'Proportion of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated patients.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (CE)', 'description': 'Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (CE+GDC-0449)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (CE+IMC-A12)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '11.2'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '12.4'}, {'value': '10.1', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '14.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry', 'description': 'Overall survival is defined as the time from randomization to death or date of last known alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated patients.'}, {'type': 'SECONDARY', 'title': 'PFS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High CTC Count', 'description': 'High CTC count is defined as greater than 100 CTCs per 7.5 ml at baseline.'}, {'id': 'OG001', 'title': 'Low CTC Count', 'description': 'Low CTC count is defined as \\<= 100 CTCs per 7.5 ml at baseline.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '5.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '5.3'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.13', 'ciUpperLimit': '2.52', 'estimateComment': 'Hazard ratio was derived comparing the high CTCs group to the low CTCs group.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry', 'description': 'Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated patients who had baseline CTC results available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (CE)', 'description': 'Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\ncisplatin: Given IV\n\netoposide: Given IV'}, {'id': 'FG001', 'title': 'Arm B (CE+GDC-0449)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.\n\nvismodegib: Given PO\n\ncisplatin: Given IV\n\netoposide: Given IV'}, {'id': 'FG002', 'title': 'Arm C (CE+IMC-A12)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\ncisplatin: Given IV\n\netoposide: Given IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'Patients Who Started Assigned Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'Eligible and Treated Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'Eligible/Treated Pts With CTCs Results', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'comment': 'Treatment continued until disease progression or unacceptable toxicity.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Treatment continued until disease progression or unacceptable toxicity.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Alternative therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Sympomatic deterioration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treatment delayed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pt had PD but was SD when re-measured', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received more tx instead of observation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Never started assigned therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants were recruited from ECOG member institutions between July, 16, 2009 and August 12, 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (CE)', 'description': 'Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\ncisplatin: Given IV\n\netoposide: Given IV'}, {'id': 'BG001', 'title': 'Arm B (CE+GDC-0449)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.\n\nvismodegib: Given PO\n\ncisplatin: Given IV\n\netoposide: Given IV'}, {'id': 'BG002', 'title': 'Arm C (CE+IMC-A12)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\ncisplatin: Given IV\n\netoposide: Given IV'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '38', 'upperLimit': '77'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '87'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '83'}, {'value': '63', 'groupId': 'BG003', 'lowerLimit': '38', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Eligible and treated patients.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2009-04-22', 'resultsFirstSubmitDate': '2015-07-01', 'studyFirstSubmitQcDate': '2009-04-22', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-01', 'studyFirstPostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry', 'description': 'Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.'}], 'secondaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': 'Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry', 'description': 'Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry', 'description': 'Overall survival is defined as the time from randomization to death or date of last known alive.'}, {'measure': 'PFS', 'timeFrame': 'Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry', 'description': 'Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Extensive Stage Small Cell Lung Carcinoma', 'Recurrent Small Cell Lung Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies cisplatin and etoposide to see how well they work when given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12 (cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide may slow the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vismodegib may slow the growth of tumor cells. Monoclonal antibodies, such as cixutumumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving cisplatin and etoposide are more effective when given together with vismodegib or cixutumumab in treating small cell lung cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the progression-free survival (PFS) of patients with extensive stage small cell lung cancer (SCLC-ED) treated with cisplatin and etoposide (CE), CE with hedgehog (HH) inhibitor GDC-0449 (vismodegib), and CE with insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody (IMC-A12) (cixutumumab).\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate response rate, overall survival, and toxicity for each arm. II. To explore putative correlates of clinical benefit from combination therapy in tumor and circulating tumor cells in patients treated on this protocol.\n\nOUTLINE: Patients are randomized to 1 of 3 treatment arms.\n\nARM A (CE): Patients receive cisplatin (75 mg/m\\^2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m\\^2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nARM B (CE +GDC-0449): Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.\n\nARM C (CE + IMC-A12): Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer (SCLC)\n* Extensive stage SCLC\n\n * Extensive stage disease: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy\n* Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST); baseline measurements and evaluations of all sites of disease must be obtained =\\< 4 weeks prior to randomization\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Absolute neutrophil count (ANC) \\>= 1,500/mm\\^3\n* Platelets \\>= 100,000/mm\\^3\n* Total bilirubin =\\< 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase) =\\< 3 x institutional ULN (=\\< 5 x ULN if liver function test \\[LFT\\] elevations are due to liver metastases)\n* Creatinine =\\< 1.5 x institutional ULN OR creatinine clearance \\>= 60 mL/min/1.73 m\\^2 for patients with creatinine levels \\> 1.5 x institutional ULN\n* Leukocytes \\>= 3,000/mm\\^3\n* Hemoglobin \\>= 9 g/dL\n* Fasting serum glucose \\< 120 mg/dL or below institutional ULN =\\< 7 days prior to protocol randomization\n* Patients with central nervous system (CNS) metastases will be eligible if they have completed a course of CNS radiotherapy and have stable neurologic function for a minimum of 28 days prior to study randomization; radiotherapy must have been completed a minimum of 28 days prior to randomization, and patients must have recovered from any adverse events related to the radiotherapy (except alopecia and grade 1 neuropathy) and have stable neurologic function for a minimum of 28 days prior to study randomization\n\n * NOTE: the use of prophylactic cranial irradiation (recommended dose 25 Gy) in those who completed protocol chemotherapy and have a response (in the absence of progressive disease \\[PD\\]) is allowed; for patients on Arms B and C, GDC-0449 and IMC-A12 will be held while patient is receiving prophylactic cranial irradiation (PCI); these agents can be reinstituted after PCI is completed\n* Women of child-bearing potential (WCBP) and men 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\n * WCBP must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse; the two methods of reliable contraception must include one highly effective method (i.e., intrauterine device \\[IUD\\], hormonal \\[birth control pills, injections, or implants\\], tubal ligation, partner?s vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, cervical cap); WCBP must be referred to a qualified provider of contraceptive methods if needed\n\n * NOTE: the WCBP randomized to Arm B must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following two additional time periods related to this study: 1) while participating in the study; and 2) for at least 12 months after discontinuation from the study\n * Before starting the study drugs, all WCBP must have a negative pregnancy test (sensitivity of at least 50 mIU/mL); the pregnancy test must be performed within 10-14 days prior to randomization\n\n * NOTE: the WCBP randomized to Arm B must have a second pregnancy test performed within the 24 hours prior to the start of the GDC-0449; the subject may not receive GDC-0449 until the investigator has verified that the results of these pregnancy tests are negative\n * The WCBP randomized to Arm B will be warned that sharing the study drug is prohibited and will be counseled about pregnancy precautions and potential risks or fetal exposure; she must also agree to abstain from donating blood during study participation and at least 12 months after discontinuation from the study drug\n\n * NOTE: male subjects randomized to Arm B must agree to use a latex condom during sexual contact with WCBP while participating in the study and for at least 12 months following discontinuation from the study even if he has undergone a successful vasectomy\n * Male subjects randomized to Arm B will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure; male subjects must agree to abstain from donating blood, semen, or sperm during study participation and for at least 3 months after discontinuation from the study drug\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding; all WCBP must have a blood test within 10-14 days prior to randomization to rule out pregnancy\n* Prior chemotherapy or biologic therapy for SCLC; patients with prior radiation may be eligible or after palliative radiotherapy for other sites of disease; patients receiving prior radiation cannot start therapy within 14 days after completion of radiation, and must have recovered from adverse events attributed to radiation; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression\n* Receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to GDC-0449 and IMC-A12 or other agents used in the study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy\n* Poorly controlled diabetes mellitus; patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting \\< 120 mg/dL or below institutional upper limit of normal) and that they are on a stable dietary or therapeutic regimen for this condition\n* Patients with major surgery, hormonal therapy (other than replacement), within 4 weeks prior to entering the study or those who have not recovered from adverse events\n* Prior treatment with other agents targeting the IGFR or the Hedgehog signaling pathway'}, 'identificationModule': {'nctId': 'NCT00887159', 'briefTitle': 'A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'NCI-2011-01917'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01917', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '09-0679'}, {'id': 'ECOG-E1508'}, {'id': 'CDR0000640898'}, {'id': 'E1508', 'type': 'OTHER', 'domain': 'ECOG-ACRIN Cancer Research Group'}, {'id': 'E1508', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180820', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180820', 'type': 'NIH'}, {'id': 'U10CA021115', 'link': 'https://reporter.nih.gov/quickSearch/U10CA021115', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A (CE)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and etoposide IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cisplatin', 'Drug: Etoposide', 'Other: Laboratory Biomarker Analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (CE + GDC-0449)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and vismodegib PO QD on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cisplatin', 'Drug: Etoposide', 'Other: Laboratory Biomarker Analysis', 'Drug: Vismodegib']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C (CE + IMC-A12)', 'description': 'Patients receive cisplatin and etoposide as in Arm A and cixutumumab IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cisplatin', 'Biological: Cixutumumab', 'Drug: Etoposide', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine Dichloride', 'Cismaplat', 'Cisplatina', 'Cisplatinum', 'Cisplatyl', 'Citoplatino', 'Citosin', 'Cysplatyna', 'DDP', 'Lederplatin', 'Metaplatin', 'Neoplatin', "Peyrone's Chloride", "Peyrone's Salt", 'Placis', 'Plastistil', 'Platamine', 'Platiblastin', 'Platiblastin-S', 'Platinex', 'Platinol', 'Platinol- AQ', 'Platinol-AQ', 'Platinol-AQ VHA Plus', 'Platinoxan', 'Platinum', 'Platinum Diamminodichloride', 'Platiran', 'Platistin', 'Platosin'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (CE)', 'Arm B (CE + GDC-0449)', 'Arm C (CE + IMC-A12)']}, {'name': 'Cixutumumab', 'type': 'BIOLOGICAL', 'otherNames': ['Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12', 'IMC-A12'], 'description': 'Given IV', 'armGroupLabels': ['Arm C (CE + IMC-A12)']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16-213', 'VP-16', 'VP-16-213'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (CE)', 'Arm B (CE + GDC-0449)', 'Arm C (CE + IMC-A12)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm A (CE)', 'Arm B (CE + GDC-0449)', 'Arm C (CE + IMC-A12)']}, {'name': 'Vismodegib', 'type': 'DRUG', 'otherNames': ['Erivedge', 'GDC-0449', 'Hedgehog Antagonist GDC-0449'], 'description': 'Given PO', 'armGroupLabels': ['Arm B (CE + GDC-0449)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute Palo Alto', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Medical Center of Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose-Saint Francis Healthcare', 'geoPoint': {'lat': 38.83388, 'lon': 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