Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Premarin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s):
William Oh, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
Official title: A Phase II Trial of Two Doses of Conjugated Estrogens (Premarin) in Patients With Androgen-Independent Prostate Cancer
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer
Secondary outcome: To evaluate the safety of Premarin in this patient population
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Dana-Farber Cancer Insitute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02115, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States
Additional Information
Starting date: March 2003
Ending date: July 2008
Last updated: December 22, 2007
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