A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
- 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
- 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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
every 8 weeks until progression
Peter J. VanVeldhuizen, MD
Kansas City Veteran Affairs Medical Center
United States: Federal Government