Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

NCT00193271 | Completed Phase 2

• 2 other identifiers: SCRI GU 19IIT16165
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate

Secondary Outcomes (2)

• Rate of recurrence

• Toxicity

Interventions

Docetaxel DRUG

Estramustine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Estramustine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anthony A. Meluch, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 3, 2011

Record last verified: 2011-05

Locations

US (1)