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A Phase II Trial of Two Doses of Conjugated Estrogens (Premarin) in Patients With Androgen-Independent Prostate Cancer

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Trial Conditions
  • Prostate Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Mark Pomerantz, MD
Trial Interventions
Drug
  • Premarin
Physician Researcher

Investigator Name:

  • Mark Pomerantz, MD

Other Information

Sponsor: Dana-Farber Cancer Institute
Phase: Phase 2
Trial ID: NCT00134654
Volunteers:  Not Accepting Healthy Volunteers

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