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

• Status: Completed
• Trial end date: 2005-12-31
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute; University of Massachusetts, Worcester
• Treatments: Bicalutamide; Docetaxel; Estramustine; Goserelin; Leuprolide

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