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Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00193271
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 3, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Drug: Estramustine Phase 2

Detailed Description:

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer
Study Start Date : August 2004
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Response Rate

Secondary Outcome Measures :
  1. Rate of recurrence
  2. Toxicity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193271


Locations
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
Investigators
Principal Investigator: Anthony A. Meluch, MD SCRI Development Innovations, LLC
More Information

Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193271     History of Changes
Other Study ID Numbers: SCRI GU 19
IIT16165
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Estramustine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal