Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00003717|
Recruitment Status : Unknown
Verified August 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 14, 2004
Last Update Posted : December 19, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than once drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: estramustine phosphate sodium Drug: paclitaxel||Phase 2|
OBJECTIVES: I. Determine the response rate (PSA and/or objective response) and duration of response to weekly paclitaxel plus estramustine in patients with metastatic hormone refractory prostate cancer. II. Determine the effect on quality of life of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour weekly for 4 weeks. Patients receive oral estramustine the day before, the day of, and the day after paclitaxel administration each week. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. A quality of life questionnaire is completed before treatment and 2 months after treatment initiation.
PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Official Title:||A Phase II Trial of Weekly Paclitaxel Plus Oral Estramustine in Patients With Hormone Refractory Prostate Cancer|
|Study Start Date :||October 1998|
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): NCT00003717
|United States, New Jersey|
|St. Barnabas Medical Center|
|Livingston, New Jersey, United States, 07039|
|Monmouth Medical Center|
|Long Branch, New Jersey, United States, 07740|
|Study Chair:||Stuart P. Leitner, MD||St. Barnabas Medical Center|