Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer Read More

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