NCT00058318

S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer

A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	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 progression
DRUG	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.

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-05-01
• Completion: 2008-11-01
• First posted: 2003-04-09
• Last updated: 2012-11-02