Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer|
|Study Start Date:||January 1999|
|Study Completion Date:||February 22, 2017|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
|Experimental: paclitaxel + vinorelbine||Drug: paclitaxel Drug: vinorelbine tartrate|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003622
|United States, District of Columbia|
|George Washington University Hospital|
|Washington, D.C., District of Columbia, United States, 20037|
|Study Chair:||James D. Ahlgren, MD||George Washington University|