Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer
- Determine the response rates in patients with metastatic or recurrent small cell lung
cancer treated with irinotecan hydrochloride and carboplatin.
- Determine the median survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (yes vs no) and disease stage (metastatic vs relapsed).
Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30
minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Evidence of disease progression during the study
Derick H. Lau, MD
University of California, Davis
United States: Federal Government
|University of California Davis Cancer Center||Sacramento, California 95817|