Kidney Cancer Clinical Trial
Official title:
Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine
together with irinotecan works in treating patients with metastatic kidney cancer.
OBJECTIVES:
- Determine the response rate in patients with epithelial (clear or nonclear cell) renal
cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan
hydrochloride.
- Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with
this regimen.
- 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.
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