capecitabine and gemcitabine in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

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.

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.

Eligibility criteria:
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

Keywords: recurrent renal cell cancer stage iv renal cell cancer