Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer
- Registration Number
- NCT00134654
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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 will also receive coumadin daily to help prevent thromboembolic disease.
After reviewing the first 30 patients on Arm A, it was determined that arm A (low dose Premarin) was not effective. Arm A was then closed and patients on Arm A were given the choice to switch to Arm B.
Treatment will continue until there is evidence of disease progression or unacceptable side effects.
Every 4 weeks while receiving Premarin, a physical exam and blood work will be performed. Every 12 weeks a CT scan of the abdomen and pelvis and a bone scan will be performed.
Patients will also be encouraged to undergo standard preventative breast irradiation prior to starting Premarin or up to 4 weeks after starting treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Premarin Premarin 3 times a day Group A Premarin Premarin once a day
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer
- Secondary Outcome Measures
Name Time Method To evaluate the safety of Premarin in this patient population 2 years
Trial Locations
- Locations (3)
Dana-Farber Cancer Insitute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States