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 DHA-paclitaxel in treating patients who have locally advanced, metastatic, or unresectable kidney cancer.
OBJECTIVES: I. Determine the tumor response rate, duration of response, and time to disease progression in patients with locally advanced, metastatic, or unresectable renal cell cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at completion of treatment. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Arizona Oncology Associates
Tucson, Arizona, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States