Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193271
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: Docetaxel
Drug: Estramustine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Response Rate

Secondary Outcome Measures:
  • Rate of recurrence
  • Toxicity

Estimated Enrollment: 30
Study Start Date: August 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193271     History of Changes
Other Study ID Numbers: SCRI GU 19, IIT16165
Study First Received: September 12, 2005
Last Updated: May 2, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014