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

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.

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)