Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma
- Determine the response rate in patients with epithelial (clear or nonclear cell) renal
cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan
- Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with
- Determine the toxicities of this regimen.
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride
IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses
in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Ronald M. Bukowski, MD
The Cleveland Clinic
United States: Federal Government
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|