Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma

NCT ID: NCT00193193

Last Updated: 2010-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paclitaxel

Intervention Type DRUG

Estramustine

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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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 2.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Principal Investigators

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John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Other Identifiers

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SCRI GU 10

Identifier Type: -

Identifier Source: org_study_id

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