A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
Overview
- Phase
- Phase 2
- Intervention
- capecitabine
- Conditions
- Kidney Cancer
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 43
- Primary Endpoint
- Response
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment
Gemcitabine + Capecitabine
Intervention: capecitabine
Treatment
Gemcitabine + Capecitabine
Intervention: gemcitabine hydrochloride
Outcomes
Primary Outcomes
Response
Time Frame: every 8 weeks until progression
Secondary Outcomes
- Survival(every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years)
- Time to treatment failure(every 8 weeks until progression)