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

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)