Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sunitinib

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