Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed newly diagnosed clear cell renal cell carcinoma, meeting 1 of the following criteria:
• * Localized disease, as evidenced by intact, bulky, and primary renal lesions (T1 \> 3 cm, any T2, T3, or T4) appropriate for nephrectomy
• * Limited metastatic disease, as evidenced by any renal primary (T1 \> 3 cm, any T2, T3, or T4) appropriate for cytoreductive nephrectomy
• * Isolated abdominal/pelvic recurrence with limited metastatic burden (minimum size \> 2 cm) appropriate for metastasectomy
• No known brain metastasis
• * Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
• PATIENT CHARACTERISTICS:
• Eastern Cooperative Oncology Group performance status 0-1
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN with liver involvement)
• Creatinine ≤ 1.5 times ULN
• Estimated glomerular filtration rate \> 30 mL/min (for patients receiving Gd-enhanced MRI)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception prior to, during (men and women), and for at least 3 months after (men) completion of study therapy
• Adequate cardiac and pulmonary status for operative therapy
• No active clinically serious infection \> CTCAE grade 2
• No known HIV, hepatitis B, or hepatitis C infections
• No serious non-healing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 4 weeks
• No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
• No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
• No history of an uncontrolled bleeding disorder including, but not limited to, any of the following:
• * Bleeding diathesis
• * Coagulopathy
• No cardiac disease or condition including, but not limited to, any of the following:
• * New York Heart Association class II-IV congestive heart failure
• * Unstable angina (anginal symptoms at rest)
• * New onset angina beginning within the last 3 months
• * Myocardial infarction within the past 6 months
• * Cardiac ventricular arrhythmias requiring antiarrhythmic therapy
• No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management
• No thrombolic or embolic events within the past 6 months (e.g., cerebrovascular accident including transient ischemic attacks)
• No condition that impairs the ability to swallow whole pills
• No malabsorption problem
• No contraindication to MRI, including, but not limited to, any of the following:
• * Ferromagnetic implants
• * Dental work
• * Pacemakers
• * Metallic implants
• * Severe claustrophobia which precludes closed MRI testing
• No known or suspected allergy to sorafenib tosylate
• No contraindication or allergy to gadolinium (e.g., end stage renal disease requiring hemodialysis)
• No intercurrent illness or situation which, in the judgment of the investigator, would affect assessments of clinical status and study endpoints significantly
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• More than 4 weeks since prior major surgery or open biopsy
• No prior therapy with tyrosine kinase or vascular endothelial growth factor inhibitors (e.g., sunitinib malate, sorafenib, or bevacizumab)
• No concurrent Hypericum perforatum (St. John's wort) or rifampin
• No concurrent use of illicit drugs or other substances that may, in the opinion of the investigator, have a reasonable chance of contributing to toxicity or interfering with study results