Kidney Cancer Clinical Trial
Official title:
A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
RATIONALE: Drugs used in chemotherapy such as gemcitabine and capecitabine use different
ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with
capecitabine in treating patients who have advanced renal cell cancer (kidney cancer).
OBJECTIVES:
- Determine response (confirmed and unconfirmed complete and partial) of patients with
advanced renal cell cancer treated with gemcitabine and capecitabine.
- Determine the 6-month time to treatment failure rate and overall survival rate of
patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
- Correlate, preliminarily, tumor response with the intratumoral content of the enzymes
involved in the activation and degradation of these drugs in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral
capecitabine twice daily on days 1-21. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 3.8-4.2
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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