Status:
COMPLETED
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Adenocarcinoma of the Prostate
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 at...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2005
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00165399
Start Date
March 1 2004
End Date
December 31 2005
Last Update
June 25 2018
Active Locations (5)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Lahey Clinic-Burlington
Burlington, Massachusetts, United States, 01805
4
University of Massachusetts Memorial Medical Center-University Campus
Worcester, Massachusetts, United States, 01655