Expired Study
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Nashville, Tennessee 37023


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.


Study summary:

Upon determination of eligibility, patients will receive: Docetaxel + Estramustine


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.


Study is Available At:


Original ID:

SCRI GU 19


NCT ID:

NCT00193271


Secondary ID:

IIT16165


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sarah Cannon Research Institute


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:


Overall Contact Information

Official Name:Anthony A. Meluch, MD
Principal Investigator
Sarah Cannon Research Institute

Study Dates

Start Date:August 2004
Completion Date:May 2007
Completion Type:Actual
Primary Completion Date:May 2007
Primary Completion Type:Actual
Verification Date:May 2011
Last Changed Date:May 2, 2011
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Toxicity
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of recurrence
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Response Rate
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Docetaxel
Intervention Type:Drug
Name:Estramustine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sarah Cannon Research Institute
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Aventis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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