A Randomized, Phase II Trial of Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin Administered Either Weekly or Every Four Weeks in the Treatment of Hormone Refractory Prostate Carcinoma

SCRI Development Innovations, LLC0 sites100 target enrollmentAugust 2000

ConditionsProstate Cancer

DrugsPaclitaxel Estramustine Carboplatin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: SCRI Development Innovations, LLC
Enrollment: 100
Primary Endpoint: Overall response rate
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.

Detailed Description

Upon determination of eligibility, patients will receive: Paclitaxel + Estramustine + Carboplatin Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.

Registry

clinicaltrials.gov

Start Date

August 2000

End Date

February 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

SCRI Development Innovations, LLC

Eligibility Criteria

Inclusion Criteria

•Adenocarcinoma of the prostate not curable with local treatment
•Disease progression while receiving hormonal therapy
•Measurable or evaluable disease
•Previous treatment with a maximum of one prior chemotherapy regimen
•ECOG performance status 0, 1, or
•Adequate bone marrow, liver and kidney function
•Able to comprehend the nature of this study and give written informed consent

Exclusion Criteria

•You cannot participate in this study if any of the following apply to you:
•Age \< 18 years
•History of treatment for an invasive malignancy within five years
•Significant heart disease
•Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.