Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma (RCC)

  • Clear cell or non-clear cell tumors allowed
  • Intermediate- or high-risk disease (Leibovich score 3 to 11)

• Must have undergone surgery for RCC at least 4 weeks but no more than 3 months prior to study entry

  • No evidence of residual macroscopic disease on post-operative CT scan after resection of RCC

PATIENT CHARACTERISTICS:

• WHO performance status 0-1
• WBC > 3,400/mm³
• Platelet count > 99,000/mm³
• Creatinine < 2.5 times upper limit of normal (ULN)
• Liver function tests < 1.5 times ULN
• Serum amylase < 1.5 times ULN
• PT/INR < 1.5 times ULN
• PTT < 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 9 months after completion of study treatment

• No cardiovascular conditions, including any of the following:

  • Cardiac arrhythmias requiring anti-arrhythmic medication

    • Beta-blockers and digoxin allowed
  • Symptomatic coronary artery disease or ischemia
  • Myocardial infarction within the past 6 months
  • NYHA class II-IV congestive heart failure
• No active clinically serious bacterial or fungal infection
• No known history of HIV infection
• No chronic hepatitis B or C
• No other prior malignancy except carcinoma in situ of the cervix or adequately treated basal cell carcinoma
• No uncontrolled hypertension

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior treatment for RCC other than nephrectomy
• More than 30 days since prior and no other concurrent investigational therapy

• No concurrent medications that have adverse interactions with sorafenib tosylate including, but not limited to, any of the following:

  • Rifampin
  • Grapefruit juice
  • Ritonavir
  • Ketoconazole
  • Itraconazole
  • Hypericum perforatum (St John's wort)
• No concurrent bone marrow transplant or stem cell rescue
• No other concurrent drug that targets angiogenesis, especially VEGF or VEGF receptors (e.g., bevacizumab)
• No other concurrent drug that targets Ras-pathway or EGFR
• No other concurrent anticancer therapy (chemotherapy, immunotherapy, signal transduction inhibition, or hormonal therapy)
• Concurrent non-conventional therapies (e.g., herbs or acupuncture) and vitamin or mineral supplements allowed
• Concurrent bisphosphonates for prophylaxis of osteoporosis allowed