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

NCT ID: NCT00165399

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2005-12-31

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.

Conditions

Adenocarcinoma of the Prostate; Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Docetaxel

Given intravenously on day 2 of four three-week cycles

Intervention Type: DRUG

Estramustine

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

Intervention Type: DRUG

Casodex

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

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Mary-Ellen Taplin, MD

Associate Professor of Medicine, HMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary-Ellen Taplin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Clinic-Burlington

Burlington, Massachusetts, United States

University of Massachusetts Memorial Medical Center-University Campus

Worcester, Massachusetts, United States

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

03-230

Identifier Type: -

Identifier Source: org_study_id

NCT00003915

Identifier Type: -

Identifier Source: nct_alias