An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic Renal Cell Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma

- Stage IV disease

- Has undergone nephrectomy

- Archival tumor tissue samples available

- No history or clinical evidence of brain metastasis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- WBC ≥ 3,000/mm^3

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance ≥ 40
mL/min

- Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN for patients with Gilbert's disease)

- AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN for patients with 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 with medication (i.e., diastolic blood
pressure ≥ 100 mm Hg despite optimal medical therapy)

- No cardiac dysrhythmias ≥ grade 2 by NCI CTCAE v3.0

- No concurrent serious illness including, but not limited to, the following:

- Ongoing or active infection requiring parenteral antibiotics

- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
myocardial infarction, or unstable angina)

- NYHA class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Peripheral vascular disease ≥ grade 2 within the past year

- Psychiatric illness and/or social situation that would limit compliance with
study requirements

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior antiangiogenesis therapy

- Prior radiotherapy to a symptomatic site of metastatic disease is allowed

- At least 2 weeks since prior radiotherapy and recovered

- No other concurrent investigational therapies

- No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
carbamazepine, or phenobarbital), rifampin, or St. John's wort