RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have advanced kidney cancer.
OBJECTIVES: * Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with advanced renal cell cancer treated with BAY 59-8862. * Determine the overall survival in patients treated with this drug. * Determine the time to progression in patients treated with this drug. * Determine the duration of response (CR and PR) in patients treated with this drug. * Determine the qualitative and quantitative toxicity profile of this drug in this patient population. * Determine the pharmacokinetic profile of this drug in selected patients. OUTLINE: This is a multicenter study. Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years. PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Scripps Clinic
La Jolla, California, United States
Medical Consultants
Muncie, Indiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
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Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
206 Research Associates
Greenbelt, Maryland, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Billings Oncology Associates
Billings, Montana, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
...and 3 more locations