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

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ClinicalTrials.gov Identifier: NCT00165399
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

September 9, 2005
September 14, 2005
June 25, 2018
March 2004
December 31, 2005   (Final data collection date for primary outcome measure)
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 ]
To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.
Complete list of historical versions of study NCT00165399 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: 2 years ]
  • 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.
Not Provided
Not Provided
 
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment

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
  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adenocarcinoma of the Prostate
  • Prostate Cancer
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
61
December 31, 2005
December 31, 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00165399
03-230
Not Provided
Not Provided
Not Provided
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP