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

Primary Purpose

Adenocarcinoma of the Prostate, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Estramustine
Casodex
Zoladex
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring Prostate cancer, PSA level, docetaxel, estramustine, hormone therapy, androgen withdrawal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Lahey Clinic-Burlington
  • University of Massachusetts Memorial Medical Center-University Campus
  • Norris Cotton Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 9, 2005
Last Updated
June 21, 2018
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00165399
Brief Title
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
Official Title
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2004 (Actual)
Primary Completion Date
December 31, 2005 (Actual)
Study Completion Date
December 31, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Prostate Cancer
Keywords
Prostate cancer, PSA level, docetaxel, estramustine, hormone therapy, androgen withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Given intravenously on day 2 of four three-week cycles
Intervention Type
Drug
Intervention Name(s)
Estramustine
Intervention Description
Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)
Intervention Type
Drug
Intervention Name(s)
Casodex
Intervention Description
Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months
Intervention Type
Drug
Intervention Name(s)
Zoladex
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To determine the PSA response rate and duration of response
Title
to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary-Ellen Taplin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic-Burlington
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center-University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
037566-0002
Country
United States

12. IPD Sharing Statement

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

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