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

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: October 2, 2007 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute Bristol-Myers Squibb
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193193

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Paclitaxel Drug: Estramustine Drug: Carboplatin	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Paclitaxel Carboplatin Estramustine phosphate sodium Estramustine Estramustine phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall response rate

Secondary Outcome Measures:

Toxicity
Overall survival

Estimated Enrollment:	100
Study Start Date:	August 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193193

Sponsors and Collaborators

Sarah Cannon Research Institute

Bristol-Myers Squibb

Investigators

Principal Investigator:

John D. Hainsworth, MD

Sarah Cannon Research Institute

More Information

No publications provided

Study ID Numbers:	SCRI GU 10
Study First Received:	September 12, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00193193 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Estramustine
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Genital Diseases, Male

Hormones
Carcinoma
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Prostatic Neoplasms
Alkylating Agents

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Mitosis Modulators
Estramustine
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009