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Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Estramustine
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tennessee Oncology, PLLC

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Rate of recurrence
Toxicity

Full Information

First Posted
September 12, 2005
Last Updated
May 2, 2011
Sponsor
SCRI Development Innovations, LLC
Collaborators
Aventis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00193271
Brief Title
Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer
Official Title
Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Aventis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Upon determination of eligibility, patients will receive: Docetaxel + Estramustine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Estramustine
Primary Outcome Measure Information:
Title
Response Rate
Secondary Outcome Measure Information:
Title
Rate of recurrence
Title
Toxicity

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony A. Meluch, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

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