Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment

NCT00165399 | Completed Phase 2

• 1 other identifier: 03-230
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer. This study will attempt to:

• stop or slow the growth of disease
• gain information about prostate cancer
• evaluate the effectiveness and side effects of the study drug

Conditions

Adenocarcinoma of the Prostate; Prostate Cancer

Keywords

Prostate cancer; PSA level; docetaxel; estramustine; hormone therapy; androgen withdrawal

Outcome Measures

Primary Outcomes (1)

• To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.

  2 years

Secondary Outcomes (2)

• To determine the PSA response rate and duration of response

• to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy.

  2 years

Interventions

Docetaxel DRUG

Given intravenously on day 2 of four three-week cycles

Estramustine DRUG

Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)

Casodex DRUG

Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months

Zoladex DRUG

Started one week after the start of casodex; zolades is given as an injection (in the stomach once every 3 months for a total of 5 injections.

Eligibility Criteria

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

You may qualify if:

• Histologically documented adenocarcinoma of the prostate
• Previous treatment with either radical prostatectomy or radiation therapy
• Post prostatectomy: PSA rising on at least two successive occasions at least two weeks apart
• Post radiation therapy alone: PSA has to be rising as documented on two successive occasions at least two weeks apart and also have doubled from the nadir post treatment value
• ECOG performance status 0-1
• ANC \> 1,500/mm3
• Platelet counts \> 100,000/mm3
• SGOT and/or SGPT may be up to 2.5 x ULN

You may not qualify if:

• Documented local recurrence of prostate cancer or documented metastatic disease
• History of other malignancy within the last 5 years, other than curatively treated basal cell carcinoma of the skin
• Medical condition requiring the use of concommitant corticosteroids
• Active infection
• Significant cardiac disease, angina pectoris or myocardial infarction within six months
• Prior chemotherapy including estramustine, suramin
• Active thrombophlebitis or history of thromboembolic events in the six months preceding study treatment
• Clinically significant neuropathy
• Elevated bilirubin above ULN

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (5)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic-Burlington

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts Memorial Medical Center-University Campus

Worcester, Massachusetts, 01655, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 037566-0002, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Estramustine; bicalutamide; Goserelin

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; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Mary-Ellen Taplin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, HMS

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: March 1, 2004
• Primary Completion: December 31, 2005
• Study Completion: December 31, 2005
• Last Updated: June 25, 2018

Record last verified: 2018-06

Locations

US (5)