NCT00003717

Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

A Phase II Trial of Weekly Paclitaxel Plus Oral Estramustine in Patients With Hormone Refractory Prostate Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: St. Barnabas Medical Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	estramustine phosphate sodium
DRUG	paclitaxel

Timeline

• Start date: 1998-10-01
• First posted: 2004-04-14
• Last updated: 2013-12-19

Locations

2 sites across 1 country: United States