Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00042965|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: capecitabine Drug: gemcitabine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
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: gemcitabine hydrochloride
- Response rate [ Time Frame: Up to 2 years ]
- Overall survival [ Time Frame: Up to 2 years ]
- Progression-free survival [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042965
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|Study Chair:||Walter M. Stadler, MD, FACP||University of Chicago|