sunitinib in treating patients with locally recurrent or metastatic kidney cancer

Conditions: Kidney Cancer

Summary: 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

Keywords: recurrent renal cell cancer stage iv renal cell cancer