Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
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.
Drug: gemcitabine hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma|
- Response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2002|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + 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.
|Drug: capecitabine Drug: gemcitabine hydrochloride|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042965
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|Study Chair:||Walter M. Stadler, MD, FACP||University of Chicago|