Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

May 2, 2011 updated by: SCRI Development Innovations, LLC

Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer

This trial will evaluate the feasibility, toxicity, and efficacy of docetaxel/estramustine, as in the adjuvant therapy of patients with high-risk prostate cancer after definitive local therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Clinically or surgically staged localized disease, stage I-III.
  • Prior surgical resection or radiation therapy with curative intent
  • No clinical evidence of residual disease
  • Gleason's combined score > 7.
  • Age > 18 years.
  • No prior chemotherapy for prostate cancer.
  • No previous androgen deprivation therapy for prostate cancer
  • Able to perform activities of daily living with minimal assistance
  • Adequate bone marrow, liver and kidney function
  • Voluntarily provide written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • History of prior malignancy in the past five years
  • History of significant heart disease within the previous 6 months
  • Cerebral vascular accident (CVA) or stroke within the previous 6 months.
  • Moderate or severe peripheral neuropathy
  • Previous therapy with other injectable radioisotopes.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response Rate

Secondary Outcome Measures

Outcome Measure
Toxicity
Rate of recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Anthony A. Meluch, MD, SCRI Development Innovations, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

May 3, 2011

Last Update Submitted That Met QC Criteria

May 2, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI GU 19
  • IIT16165

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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