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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165399
• Other study ID #: 03-230
• Status: Completed
• Phase: Phase 2
• Start date: March 2004
• Est. completion date: December 31, 2005

Study information

• Verified date: June 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT00003915

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2005
• Est. primary completion date: December 31, 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel
Given intravenously on day 2 of four three-week cycles
• Estramustine
Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)
• Casodex
Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Lahey Clinic-Burlington	Burlington	Massachusetts
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	University of Massachusetts Memorial Medical Center-University Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.		2 years
Secondary	To determine the PSA response rate and duration of response
Secondary	to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy.		2 years