DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
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 metastatic prostate cancer that has not responded to hormone therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer|
|Study Start Date:||April 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024414
|United States, Arizona|
|Arizona Oncology Associates|
|Tucson, Arizona, United States, 85712-2254|
|United States, California|
|Alta Bates Comprehensive Cancer Center|
|Berkeley, California, United States, 94704|
|United States, Kentucky|
|Lucille Parker Markey Cancer Center, University of Kentucky|
|Lexington, Kentucky, United States, 40536-0098|
|United States, Louisiana|
|Louisiana State University Health Sciences Center - Shreveport|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, New Jersey|
|Veterans Affairs Medical Center - East Orange|
|East Orange, New Jersey, United States, 07019|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|Study Chair:||Michael A. Carducci, MD||Sidney Kimmel Comprehensive Cancer Center|