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