Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works 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.

Eligibility Criteria:
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