Prostate Cancer Clinical Trial
Official title:
Phase II Study of Vinorelbine With Paclitaxel in the Treatment of 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 vinorelbine plus paclitaxel in treating
patients with metastatic prostate cancer that is refractory to hormone therapy.
OBJECTIVES: I. Determine the clinical benefit response (including improvement in quality of
life) of vinorelbine and paclitaxel in patients with metastatic hormone-refractory prostate
cancer. II. Correlate PSA response with clinical benefit response in these patients. III.
Determine the objective response rate and duration of remission in patients with measurable
disease treated with this regimen. IV. Further assess the toxicity of this combination in a
cohort of prostate cancer patients. V. Examine the survival characteristics of these patients
undergoing this regimen.
OUTLINE: This an open label study. Patients receive vinorelbine IV over 6-10 minutes on days
1, 2, and 3 and paclitaxel IV over 3 hours on day 3 following vinorelbine. Course repeats
every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life
is assessed before each treatment course. Patients are followed until death.
PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study over 15-30 months.
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