DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed renal cell cancer (RCC)

  • Metastatic (M1) or unresectable (M0) disease

  • Must have a component of clear cell RCC

    • Patients with any of the following are not eligible:

      • True papillary RCC
      • Sarcomatoid features without any clear cell component
      • Chromophobe
      • Oncocytoma
      • Collecting duct tumors
      • Transitional cell carcinoma

• Measurable disease

  • Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease

• No prior or current brain metastases

  • Patients with clinical suspicion of brain metastases must have a negative brain CT scan or MRI AND have no new symptoms of brain metastases since radiographic evaluation

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin normal
• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)

Renal

• Creatinine normal (≤ 2 times ULN for patients who have undergone prior nephrectomy) OR
• Creatinine clearance ≥ 60 mL/min

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Able to swallow oral medication intact
• 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 that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior interferon, interleukin-2, or other biologic response modifiers for RCC
• No prior antiangiogenic therapy for RCC

Chemotherapy

• No prior chemotherapy for RCC

Endocrine therapy

• No prior hormonal therapy for RCC
• Prior thyroid medications allowed

• No concurrent systemic corticosteroid therapy

  • Concurrent topical and/or inhaled steroids allowed

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to ≥ 25% of bone marrow

Surgery

• At least 4 weeks since prior surgery and recovered
• Prior resection of the primary tumor in patients with metastatic disease allowed

Other

• No prior experimental systemic therapy for RCC
• No other prior systemic therapy for RCC

• No concurrent inhibitors of CYP3A4 enzyme, including any of the following:

  • Ketoconazole
  • Itraconazole
  • Ritonavir
  • Grapefruit juice
  • Cyclosporine
  • Carbamazepine
  • Phenytoin
  • Phenobarbital