A Histopathologic and Imaging Study of Renal Cell Carcinoma Vasculature in the Setting of Sunitinib Therapy Prior to Cytoreductive Nephrectomy

Inclusion Criteria

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