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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed renal cell carcinoma Metastatic (M1) disease OR M0 provided the primary tumor is unresectable Measurable disease At least 1 unidimensionally measurable lesion Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease Soft tissue disease within a prior radiation field is measurable provided it has progressed since therapy and there is also measurable disease outside of the irradiated field No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (SGOT) no greater than 1.5 times ULN Renal Creatinine clearance at least 50 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Fertile patients must use effective contraception No other concurrent uncontrolled illness that would preclude study participation No psychiatric illness or social situation that would preclude study compliance No uncontrolled diabetes mellitus No ongoing or active infection No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy No more than 2 prior immunotherapy regimens comprising interferon (IFN) and/or interleukin-2 (IL-2) At least 28 days since prior IFN or IL-2 and recovered Chemotherapy No prior chemotherapy for renal cell cancer Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior radiotherapy to 25% or more of the bone marrow At least 21 days since prior radiotherapy and recovered Surgery At least 28 days since prior surgery and recovered Prior resection of the primary tumor allowed (in patients with metastatic disease) Other At least 4 weeks since prior sorivudine or brivudine No concurrent sorivudine or chemically related analogues (e.g., brivudine)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Gemcitabine + Capecitabine | Drug: capecitabine<br>* 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<br>Drug: gemcitabine hydrochloride<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  | every 8 weeks until progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, stage III renal cell cancer