Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma

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 confirmed renal cell carcinoma Clinically confirmed metastatic disease (histologic documentation of metastatic disease not required) Sarcomatoid renal cell carcinomas allowed No pure sarcomas No collecting duct (duct of Bellini) tumors, oncocytomas, or transitional cell tumors Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Nonmeasurable lesions include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Patients with known brain metastases are eligible if they have undergone prior surgical resection and/or cranial irradiation, they currently do not require steroids or anticonvulsants, and there is no progressive disease on CT scan or MRI at least 4 weeks after completion of radiotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic 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 Renal Creatinine clearance at least 30 mL/min Cardiac No clinically significant cardiac disease No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmias not well controlled with medication No myocardial infarction within the past 12 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study No prior severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil No malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract that would preclude absorption of capecitabine PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 4 weeks since prior chemotherapy and recovered No prior gemcitabine No prior fluoropyrimidines (e.g., fluorouracil, floxuridine, capecitabine, or fluorouracil-uracil) No other concurrent chemotherapy Endocrine therapy See Disease Characteristics At least 4 weeks since prior megestrol No concurrent hormones (e.g., megestrol) except steroids for adrenal failure, hormones for nondisease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Prior radiotherapy to any lesion that may produce disability (e.g., unstable femur) allowed No concurrent palliative radiotherapy Surgery See Disease Characteristics At least 4 weeks since prior major surgery and recovered Other Any number of prior regimens allowed

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: Gemcitabine + capecitabine<br>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<br> <br> Drug: gemcitabine hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to 2 years | 
| Progression-free survival |  | Up to 2 years | 

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