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

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Lowell General Hospital
South Shore Hospital
Emerson Hospital
Saint Anne's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00134654
First received: August 24, 2005
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Premarin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Two Doses of Conjugated Estrogens (Premarin) in Patients With Androgen-Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of Premarin in this patient population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: March 2003
Study Completion Date: June 2011
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134654

Locations
United States, Massachusetts
Dana-Farber Cancer Insitute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Lowell General Hospital
South Shore Hospital
Emerson Hospital
Saint Anne's Hospital
Investigators
Principal Investigator: Mark Pomerantz, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Mark Pomerantz, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00134654     History of Changes
Other Study ID Numbers: 02-306
Study First Received: August 24, 2005
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Androgen-independent prostate cancer
Premarin
conjugated estrogen

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014