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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134654
• Other study ID #: 02-306
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2005
• Last updated: June 14, 2011
• Start date: March 2003
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2011
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Insitute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Emerson Hospital, Concord, MA, Lowell General Hospital, Massachusetts General Hospital, Saint Anne's Hospital, South Shore Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer		TBD	No
Secondary	To evaluate the safety of Premarin in this patient population		2 years	Yes