Status:
COMPLETED
Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Conditions:
Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if Premarin is useful against androgen-independent prostate cancer and to help understand how drugs such as Premarin may work.
Detailed Description
Patients will be randomly assigned to one of two study groups (arm A or Arm B). Arm A will receive 1.25mg of Premarin once daily and arm B will receive 1.25mg of Premarin three times a day. Patients w...
Eligibility Criteria
Inclusion
- Documented histologic evidence of prostate cancer.
- Progressive androgen-independent prostate cancer as defined by the Prostate-Specific Antigen (PSA) Working Group after conventional androgen deprivation and antiandrogen withdrawal.
- PSA \> 2ng/ml and serum testosterone of \< 50ng/ml
- No history of thromboembolic disease within the prior year
- ECOG performance status of 0-2
- Creatinine \< 2 x upper limit of normal
- Bilirubin \< 2 x upper limit of normal
- AST \< 2 x upper limit of normal
Exclusion
- Unstable angina or change in anginal symptoms within the past 6 months.
- Prior therapy with estrogens or PC-SPECS.
- Concurrent megestrol acetate or steroid hormones
- Major surgery or radiation therapy within 4 weeks
- Strontium-89 or samarium-153 therapy within 8 weeks
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00134654
Start Date
March 1 2003
End Date
June 1 2011
Last Update
June 16 2011
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Insitute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115