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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165399
First received: September 9, 2005
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Adenocarcinoma of the Prostate
Prostate Cancer
 Drug: Docetaxel
Drug: Estramustine
Drug: Casodex
Drug: Zoladex
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the PSA response rate and duration of response [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: March 2004
Estimated Study Completion Date: June 2013
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel
    Given intravenously on day 2 of four three-week cycles
    Drug: Estramustine
    Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)
    Drug: Casodex
    Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months
    Drug: Zoladex
    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.
Detailed Description:
  • Patients will receive two medications; docetaxel and estramustine. Estramustine will be taken orally three times daily for 5 days starting on day one. Docetaxel will be given intravenously on day 2. These two drugs will be repeated every 3 weeks for a total of 4 cycles (12 weeks).
  • Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects.
  • Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots.
  • After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment. Three weeks after the last chemotherapy treatment, patients will start Casodex orally once daily.
  • After taking Casodex for 1 week, patients will then start on Zoladex (an injection in the abdomen) every 3 months for a total of 5 injections.
  • During study treatment various blood tests will be performed to watch the disease. Study treatment will stop after a total of 18 months (3 months chemotherapy and 15 months hormone therapy). A physical exam and blood tests will be performed every 3 months for 2 years, every 4 months for the third year, and then every 6 months after that.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165399

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Mary-Ellen Taplin, MD, Associate Professor of Medicine, HMS, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165399     History of Changes
Other Study ID Numbers: 03-230
Study First Received: September 9, 2005
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Prostate cancer
PSA level
docetaxel
 estramustine
hormone therapy
androgen withdrawal

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Estramustine
 Goserelin
Docetaxel
Bicalutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Androgen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013