Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193271
• Other study ID #: SCRI GU 19
• Secondary ID: IIT16165
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 2, 2011
• Start date: August 2004
• Est. completion date: May 2007

Study information

• Verified date: May 2011
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel

• Estramustine

Locations

Country	Name	City	State
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate
Secondary	Rate of recurrence
Secondary	Toxicity