Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Emerson Hospital, Concord, MA; Lowell General Hospital; Massachusetts General Hospital; Saint Anne's Hospital; South Shore Hospital
• Treatments: Androgens; Estrogens; Estrogens, Conjugated (USP)

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