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

June 14, 2011 updated by: Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Insitute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Premarin once a day
Drug: Premarin
Group A: 1.25mg once a day Group B: 1.25mg three time a day Group A has been closed and participants have been given the option of enrolling in Group B. Treamtment can continue until disease progression or serious side effects.
Active Comparator: Group B
Premarin 3 times a day
Drug: Premarin
Group A: 1.25mg once a day Group B: 1.25mg three time a day Group A has been closed and participants have been given the option of enrolling in Group B. Treamtment can continue until disease progression or serious side effects.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of Premarin in this patient population
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Lowell General Hospital
Saint Anne's Hospital
South Shore Hospital
Emerson Hospital, Concord, MA

Investigators

  • Principal Investigator: Mark Pomerantz, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (Estimate)

August 25, 2005

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Premarin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe