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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00134654

Run by

Dana-Farber Cancer Institute

People needed

48

Starts

2003-03-01

Expected to finish

2011-06-01

Last updated by the study team

2011-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Insitute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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