Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer
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.
Primary Purpose: Treatment
James D. Ahlgren, MD
George Washington University
United States: Federal Government
|George Washington University Hospital||Washington, District of Columbia 20037|