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

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer Read More

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