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Type(s) of Cancer
Lung
Study Phase
Phase 2
Study Completion Date
November 2016
NCT00887159Uploaded 12-11-2020
Access via NCI by Request
PDS UID: nci-data-439
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
Provider Information
Provider Data DescriptionThere are two different submissions (each with one dataset) for PMID 27163943 from trial ECOG-ACRIN 1508. This dataset, NCT00887159-D1, contains baseline, treatment, and efficacy data. Dataset NCT00887159-D2 contains toxicity data.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsExtensive Stage Small Cell Lung Carcinoma
Recurrent Small Cell Lung Carcinoma
Intervention TypeDrug: Cisplatin
Biological: Cixutumumab
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Vismodegib
Drug(s)Drug: Cisplatin
Drug: Etoposide
Drug: Vismodegib
Total Enrolled168
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (CE) - Active Comparator
Arm B (CE + GDC-0449) - Experimental
Arm C (CE + IMC-A12) - Experimental
Secondary IDNCI-2011-01917
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00887159-D1
Data DictionaryNCT00887159-D1-Data-Dictionary_2.pdf
DATANCT00887159-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00887159-D2
Data DictionaryNCT00887159-D2-Data-Dictionary_3.pdf
DATANCT00887159-D2-Dataset_2.csv
OTHERREADME.pdf
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