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

Inclusion 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