Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer
- Determine the objective tumor response rate or prostate-specific antigen response,
duration of response, and time to disease progression in patients with metastatic
hormone-refractory prostate cancer treated with DHA-paclitaxel.
- Determine the overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- 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 off study.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.
Primary Purpose: Treatment
Michael A. Carducci, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Veterans Affairs Medical Center - East Orange||East Orange, New Jersey 07018-1095|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|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|
|Alta Bates Comprehensive Cancer Center||Berkeley, California 94704|
|Arizona Oncology Associates||Tucson, Arizona 85712-2254|