Enzastaurin, Carboplatin, and Gemcitabine With or Without Bevacizumab in Treating Patients With Recurrent, Stage IIIB, or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Enzastaurin 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. Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Giving enzastaurin together with carboplatin and gemcitabine, with or without bevacizumab, may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving enzastaurin together with carboplatin and gemcitabine, with or without bevacizumab, works in treating patients with recurrent, stage IIIB, or stage IV non-small cell lung cancer.
Drug: enzastaurin hydrochloride
Drug: gemcitabine hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Enzastaurin Plus Carboplatin and Gemcitabine (ECoG) in Bevacizumab-Ineligible Patients and Enzastaurin Plus Carboplatin, Gemcitabine and Bevacizumab (B-ECoG) in Bevacizumab-Eligible Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
- Progression-free survival at 6 months (group 1)
- Progression-free survival at 4.5 months (group 2)
|Study Start Date:||June 2007|
- Determine the progression-free survival in patients with recurrent or stage IIIB or IV non-small cell lung cancer treated with carboplatin, gemcitabine, and enzastaurin with or without bevacizumab.
- Determine the toxicity of this regimen in these patients.
- Determine the overall survival in patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups based on eligibility for bevacizumab therapy.
- Group 1 (bevacizumab-eligible): Patients receive carboplatin IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1; gemcitabine hydrochloride IV over 30 minutes on days 1 and 8; and oral enzastaurin hydrochloride 3 or 4 times daily on days 1-21 in courses 1-6 and bevacizumab IV over 30-90 minutes on day 1 and oral enzastaurin hydrochloride 3 times daily on days 1-21 in all subsequent courses.
- Group 2 (bevacizumab-ineligible): Patients receive carboplatin, gemcitabine hydrochloride, and enzastaurin hydrochloride as in group 1 in courses 1-6 and enzastaurin hydrochloride alone 3 times daily on days 1-21 in all subsequent courses.
In both groups, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469976
|Study Chair:||Athanassios Argiris, MD||University of Pittsburgh|
|Investigator:||Chandra P. Belani, MD||Milton S. Hershey Medical Center|