Sunitinib Before and After Surgery in Treating Patients With Stage IV Kidney Cancer

DISEASE CHARACTERISTICS:

• Diagnosis of renal cell carcinoma

  • AJCC stage IV disease
• Radiographic evidence of disease for which cytoreductive nephrectomy is deemed to be clinically indicated AND for which preoperative embolization is not deemed necessary by the surgeon
• No history or clinical evidence of brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• WBC ≥ 3,000/mm³
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR serum creatinine clearance ≥ 40 mL/min
• Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert's disease)
• AST/ALT ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases)
• INR ≤ 1.5*
• PTT normal*
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication
• No hypertension that cannot be controlled by medications (i.e., diastolic BP ≥ 100 mm Hg despite optimal medical therapy)
• No ongoing cardiac dysrhythmias ≥ grade 2 (according to NCI CTCAE v3.0)
• No other concurrent malignancies

• No concurrent serious illness including, but not limited to, any of the following:

  • Ongoing or active infection requiring parenteral antibiotics
  • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina)
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Peripheral vascular disease ≥ grade 2 within the past year
  • Psychiatric illness/social situation that would limit compliance with study requirements NOTE: *Patients who are taking warfarin must have documentation of an INR ≤ 1.5 and PTT normal prior to the initiation of anticoagulation to rule out a baseline coagulopathy

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior radiotherapy and recovered
• Prior radiotherapy to a symptomatic site of metastatic disease is allowed
• No prior systemic therapy
• No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
• No other concurrent investigational agents