Prostate Cancer Clinical Trial
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
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.
OBJECTIVES:
- 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
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