A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy

Inclusion Criteria

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