Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

OBJECTIVES:

Primary

• Determine the safety of sunitinib malate in patients with localized or metastatic renal cell carcinoma.
• Determine the safety of surgery after 90 days of treatment with sunitinib malate in these patients.

Secondary

• Determine response of these patients after 90 days of treatment with sunitinib malate.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.

After completion of study treatment, patients are followed for 3 months.

DISEASE CHARACTERISTICS:

• Newly diagnosed renal cell carcinoma

• Clinical stage T1b, T2, or T3 tumor with or without nodal or hematogenous metastasis
• Localized or metastatic disease by renal biopsy
• Primary tumor must be amenable to surgical removal
• No history of or known spinal cord compression or carcinomatous meningitis OR evidence of symptomatic brain or leptomeningeal disease by CT scan or MRI

• Treated, stable, and asymptomatic brain metastases are allowed

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• ANC ≥ 1,500/mm^3
• Platelets ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL
• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy)
• Total bilirubin ≤ 1.5 times ULN
• Creatinine < 2 mg/dL OR creatinine clearance > 40 mL/min
• Calcium ≤ 10.2 mg/dL
• QTc interval < 500 msec
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 (male)-6 (female) months after completion of study treatment
• No serious intercurrent illness including, but not limited to, any of the following:

• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina)
• New York Heart Association ≥ class II congestive heart failure
• Serious cardiac arrhythmia requiring medication
• Peripheral vascular disease ≥ grade 2
• Psychiatric illness/social situations that would limit compliance with study requirements
• None of the following conditions within the past 6 months:

• Myocardial infarction
• Severe/unstable angina
• Coronary/peripheral artery bypass graft
• Symptomatic congestive heart failure
• Cerebrovascular accident or transient ischemic attack
• Pulmonary embolism
• No ongoing cardiac dysrhythmias NCI CTCAE version 3.0 ≥ grade 2
• No hypertension that cannot be controlled by medications (i.e., diastolic blood pressure > 100 mm Hg despite optimal medical therapy)
• No known HIV positivity

PRIOR CONCURRENT THERAPY:

• Not specified