Status:
COMPLETED
Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00193271
Start Date
August 1 2004
End Date
May 1 2007
Last Update
May 3 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023