Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion In Patients With Metastatic, Locally Advanced, or Unresectable Renal Cell Carcinoma
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.
Primary Purpose: Treatment
Ronald M. Bukowski, MD
The Cleveland Clinic
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Louisiana State University Health Sciences Center - Shreveport||Shreveport, Louisiana 71130-3932|
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|
|Lucille Parker Markey Cancer Center, University of Kentucky||Lexington, Kentucky 40536-0093|
|Arizona Oncology Associates||Tucson, Arizona 85712-2254|