Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
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|ClinicalTrials.gov Identifier: NCT00003622|
Recruitment Status : Withdrawn (No recruitment)
First Posted : May 3, 2004
Last Update Posted : July 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: paclitaxel Drug: vinorelbine tartrate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer|
|Study Start Date :||January 1999|
|Primary Completion Date :||May 2008|
|Study Completion Date :||February 22, 2017|
|Experimental: paclitaxel + vinorelbine||Drug: paclitaxel Drug: vinorelbine tartrate|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|