Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer
A Phase II Trial of Two Doses of Conjugated Estrogens (Premarin) in Patients With Androgen-Independent Prostate Cancer
1 other identifier
interventional
48
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 prostate-cancer
Started Mar 2003
Longer than P75 for phase_2 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
August 25, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 16, 2011
June 1, 2011
2.3 years
August 24, 2005
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer
Secondary Outcomes (1)
To evaluate the safety of Premarin in this patient population
2 years
Study Arms (2)
Group A
ACTIVE COMPARATORPremarin once a day
Group B
ACTIVE COMPARATORPremarin 3 times a day
Interventions
Group A: 1.25mg once a day Group B: 1.25mg three time a day Group A has been closed and participants have been given the option of enrolling in Group B. Treamtment can continue until disease progression or serious side effects.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Beth Israel Deaconess Medical Centercollaborator
- Massachusetts General Hospitalcollaborator
- Brigham and Women's Hospitalcollaborator
- Lowell General Hospitalcollaborator
- South Shore Hospitalcollaborator
- Emerson Hospital, Concord, MAcollaborator
- Saint Anne's Hospitalcollaborator
Study Sites (3)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Insitute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Pomerantz, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 24, 2005
First Posted
August 25, 2005
Study Start
March 1, 2003
Primary Completion
July 1, 2005
Study Completion
June 1, 2011
Last Updated
June 16, 2011
Record last verified: 2011-06