Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

OBJECTIVES:

Primary

• Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28 days and every 2 months thereafter.

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