S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) 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).
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer|
- Response [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]
- Survival [ Time Frame: every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Study Completion Date:||November 2008|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Gemcitabine + Capecitabine
Capecitabine will be given 625 mg/m^2 (1250 mg/m^2/day) by mouth twice a day on day 1-21 for every cycle (1 cycle =28 days) until disease progressionDrug: gemcitabine hydrochloride
Gemcitabine will be given 900 mg/m^2 by intravenous infusion over 30 minutes on day 1, 8, and 15 for every cycle (1 cycle = 28 days) until disease progression.
- 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.
|Study Chair:||Peter J. VanVeldhuizen, MD||Kansas City Veteran Affairs Medical Center|