A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed renal cell carcinoma (any histology)
meeting 1 of the following criteria:

- Metastatic disease

- No evidence of distant metastatic disease on CT scan of chest/abdomen/pelvis,
bone scan, and brain imaging (CT scan or MRI)

- Unresectable primary tumor due to any of the following factors:

- Large tumor size (> 15 cm)

- Bulky lymphadenopathy (> 4 cm or encasement of renal vessels or great vessels)

- Venous thrombosis (high level/invasive disease requiring inferior vena cava
reconstruction or hypothermic circulatory arrest)

- Proximity to vital structures (e.g., mesenteric vasculature)

- No known brain metastases, spinal cord compression, carcinomatous meningitis, or new
evidence of brain leptomeningeal disease by CT scan or MRI

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL (transfusion allowed)

- Serum calcium ≤ 12.0 mg/dL

- Creatinine ≤ 2.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No evidence of bleeding diathesis or coagulopathy (hematuria from primary renal tumor
allowed)

- None of the following within the past 6 months:

- Myocardial infarction

- Severe or unstable angina

- Severe peripheral vascular disease (claudication) or procedure on peripheral
vasculature

- Coronary/peripheral artery bypass graft

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

- Cerebrovascular accident or transient ischemic attack

- Clinically significant bleeding

- Deep venous thrombosis

- Pulmonary embolism

- No hypertension that cannot be controlled by medications to blood pressure < 160/90
mm Hg

- No known HIV positivity or AIDS

- No other severe acute or chronic medical or psychiatric conditions or laboratory
abnormality that may increase the risk associated with study participation

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior systemic treatment for renal cell carcinoma

- No other concurrent anticancer agents or therapies, including chemotherapy,
biological response modifiers, hormonal therapy, palliative radiotherapy, or
immunotherapy

- No concurrent inducers or inhibitors of CYP3A4

- No other concurrent investigational drugs

- No concurrent participation in another clinical trial