Kidney Cancer Clinical Trial
Official title:
Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different
ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan
works in treating patients with locally advanced unresectable or metastatic kidney cancer.
OBJECTIVES:
Primary
- Determine response in patients with locally advanced unresectable or metastatic renal
cell carcinoma treated with gemcitabine and irinotecan.
Secondary
- Determine the duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine median and progression-free survival in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on
days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease
progression or unacceptable toxicity. Patients receive 2 additional courses beyond best
response.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 30 months.
;
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