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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer

Outcome Time Frame:


Safety Issue:


Principal Investigator

Mark Pomerantz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2003

Completion Date:

June 2011

Related Keywords:

  • Prostate Cancer
  • Androgen-independent prostate cancer
  • Premarin
  • conjugated estrogen
  • Prostatic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana-Farber Cancer Insitute Boston, Massachusetts  02115