Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Interventions
- Registration Number
- NCT00042965
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining capecitabine with gemcitabine in treating patients who have metastatic kidney cancer.
- Detailed Description
OBJECTIVES:
* Determine the objective response rate in patients with metastatic renal cell carcinoma treated with gemcitabine and capecitabine.
* Determine the duration of overall and progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine + capecitabine capecitabine Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year and then every 6 months for 1 year. Gemcitabine + capecitabine gemcitabine hydrochloride Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
- Primary Outcome Measures
Name Time Method Response rate Up to 2 years
- Secondary Outcome Measures
Name Time Method Overall survival Up to 2 years Progression-free survival Up to 2 years
Trial Locations
- Locations (50)
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Scroll for more (40 remaining)Rebecca and John Moores UCSD Cancer Center🇺🇸La Jolla, California, United States