Correlation of Pathologic Findings After Neo-adjuvant Sorafenib With Results of Diffusion-Weighted Magnetic Resonance Imaging in Patients With Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed clear cell renal cell carcinoma, meeting 1
of the following criteria:

- Localized disease, as evidenced by intact, bulky, and primary renal lesions (T1
> 3 cm, any T2, T3, or T4) appropriate for nephrectomy

- Limited metastatic disease, as evidenced by any renal primary (T1 > 3 cm, any
T2, T3, or T4) appropriate for cytoreductive nephrectomy

- Isolated abdominal/pelvic recurrence with limited metastatic burden (minimum
size > 2 cm) appropriate for metastasectomy

- No known brain metastasis

- Patients with neurological symptoms must undergo a CT scan/MRI of the brain to
exclude brain metastasis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Hemoglobin ≥ 9.0 g/dL

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN with liver involvement)

- Creatinine ≤ 1.5 times ULN

- Estimated glomerular filtration rate > 30 mL/min (for patients receiving Gd-enhanced
MRI)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to, during (men and women),
and for at least 3 months after (men) completion of study therapy

- Adequate cardiac and pulmonary status for operative therapy

- No active clinically serious infection > CTCAE grade 2

- No known HIV, hepatitis B, or hepatitis C infections

- No serious non-healing wound, ulcer, or bone fracture

- No significant traumatic injury withing the past 4 weeks

- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks

- No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks

- No history of an uncontrolled bleeding disorder including, but not limited to, any of
the following:

- Bleeding diathesis

- Coagulopathy

- No cardiac disease or condition including, but not limited to, any of the following:

- New York Heart Association class II-IV congestive heart failure

- Unstable angina (anginal symptoms at rest)

- New onset angina beginning within the last 3 months

- Myocardial infarction within the past 6 months

- Cardiac ventricular arrhythmias requiring antiarrhythmic therapy

- No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or
diastolic BP > 100 mm Hg) despite optimal medical management

- No thrombolic or embolic events within the past 6 months (e.g., cerebrovascular
accident including transient ischemic attacks)

- No condition that impairs the ability to swallow whole pills

- No malabsorption problem

- No contraindication to MRI, including, but not limited to, any of the following:

- Ferromagnetic implants

- Dental work

- Pacemakers

- Metallic implants

- Severe claustrophobia which precludes closed MRI testing

- No known or suspected allergy to sorafenib tosylate

- No contraindication or allergy to gadolinium (e.g., end stage renal disease requiring
hemodialysis)

- No intercurrent illness or situation which, in the judgment of the investigator,
would affect assessments of clinical status and study endpoints significantly

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 weeks since prior major surgery or open biopsy

- No prior therapy with tyrosine kinase or VEGF inhibitors (e.g., sunitinib malate,
sorafenib, or bevacizumab)

- No concurrent Hypericum perforatum (St. John's wort) or rifampin

- No concurrent use of illicit drugs or other substances that may, in the opinion of
the investigator, have a reasonable chance of contributing to toxicity or interfering
with study results