|Cisplatin and Etoposide Phosphate With or Without GDC-0449 or Cixutumumab in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This randomized phase II trial is studying cisplatin and etoposide phosphate to see how well they work when given with or without GDC-0449 or cixutumumab in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GDC-0449 may slow the growth of tumor cells. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving cisplatin and etoposide are more effective when given together with GDC-0449 or cixutumumab in treating small cell lung cancer
Further Study Information
I. To evaluate the progression-free survival of patients with extensive stage small cell lung cancer treated with cisplatin and etoposide with or without Hedgehog antagonist GDC-0449 or cixutumumab.
I. To evaluate the response rate in patients treated with these regimens. II. To evaluate the overall survival of patients treated with these regimens. III. To evaluate the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to gender. Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive cisplatin IV over 1-2 hours on day 1 and etoposide phosphate 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.
ARM II: Patients receive cisplatin and etoposide phosphate as in arm I and oral Hedgehog antagonist GDC-0449 once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive Hedgehog antagonist GDC-0449 alone once daily in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive cisplatin and etoposide phosphate as in arm I 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.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.
Trial Lead Organizations/Sponsors
National Cancer Institute
Link to the current ClinicalTrials.gov record.
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.