Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced renal cell carcinoma of papillary or other non-clear cell histology

  • Metastatic or locally recurrent disease

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

  • The following are considered nonmeasurable disease:

    • Bone lesions
    • Ascites
    • Peritoneal carcinomatosis or miliary lesions
    • Pleural or pericardial effusions
    • Lymphangitis of the skin or lung
    • Cystic lesions
    • Irradiated lesions
• Patients with primary tumor in place who are eligible for surgery must have undergone prior partial or radical nephrectomy
• No history of or known brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Calcium ≤ 12.0 mg/dL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN (5 times ULN if liver function abnormalities are due to underlying malignancy)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No hemorrhage ≥ grade 3 within the past 4 weeks
• No diagnosis of any second malignancy within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer

• None of the following within the past 6 months:

  • Myocardial infarction
  • Severe or unstable angina
  • Coronary or peripheral artery bypass graft
  • Symptomatic congestive heart failure
  • Cerebrovascular accident or transient ischemic attack
  • Pulmonary embolism
• No ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade
• No prolongation of the QTc interval to > 450 msec (males) or > 470 msec (females)
• No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite optimal medical therapy)
• No pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication
• No known HIV or AIDS-related illness
• No other active infection
• No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior sunitinib malate
• Prior or concurrent bisphosphonates allowed
• More than 4 weeks since prior radiotherapy and recovered
• Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable lesion that has not been irradiated
• More than 4 weeks since prior major surgery and recovered

• No concurrent therapeutic doses of warfarin

  • Low-dose warfarin ≤ 2 mg daily for thromboprophylaxis allowed
  • Concurrent low molecular weight heparin for full anticoagulation allowed
• No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy
• No other concurrent investigational drugs

• No concurrent treatment on another clinical trial

  • Concurrent participation on supportive care trials or nontreatment trials (e.g., quality of life trials) allowed