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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.
OBJECTIVES: Primary * Determine the safety of sunitinib malate in patients with localized or metastatic renal cell carcinoma. * Determine the safety of surgery after 90 days of treatment with sunitinib malate in these patients. Secondary * Determine response of these patients after 90 days of treatment with sunitinib malate. OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy. After completion of study treatment, patients are followed for 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
oral
IV
Surgery
Roswell Park Cancer Institute
Buffalo, New York, United States
Safety of Sunitinib Malate (SM)
Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.
Time frame: 90 days
Safety of Surgery After 90 Days of Treatment With SM
Incident Rate: Intraoperative Complication Rate
Time frame: 90 days
Response Rate After 90 Days of Treatment With SM
Time frame: 90 days
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