Docetaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

Phase 1

• Conditions: Prostate Cancer

• Registration Number: NCT00002775
• Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel and estramustine in treating patients who have metastatic prostate cancer.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose, toxicity, and pharmacokinetic profile of docetaxel in combination with estramustine in patients with metastatic adenocarcinoma of the prostate. II. Determine the safe dose level of this regimen for Phase II evaluation. III. Determine the efficacy of this regimen with evaluation of objective response rate, duration of response, and time to disease progression in these patients. IV. Determine the duration of survival of these patients on this regimen. V. Evaluate the symptomatic and quality of life effects in these patients.

OUTLINE: This is a dose escalation study (phase I). Patients are stratified into one of two risk groups by number of prior chemotherapy regimens (0-2 vs greater than 2) and occurrence and site(s) of prior radiation. Patients receive oral estramustine three times daily beginning 24 hours prior to docetaxel and continuing for 4 days after infusion. Patients receive docetaxel IV over 1 hour every 21 days. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached (phase I). The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. A minimum of 6 patients receive treatment at the MTD. Phase II: Patients receive docetaxel IV at the MTD from phase I. Treatment continues in the absence of disease progression or unacceptable toxicity for both phases. Quality of life is assessed. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 13-19 months.

Study Timeline

• Study Start: 1998-02
• Study First Submitted: 1999-11-01
• Status Verified: 2000-04
• Study First Submitted QC: 2004-09-01
• Study First Posted: 2004-09-02
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Herbert Irving Comprehensive Cancer Center; 🇺🇸 New York, New York, United States