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

Tracking Information

First Received Date ^ICMJE

August 24, 2005

Last Updated Date

October 30, 2009

Start Date ^ICMJE

March 2003

Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00134654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To evaluate the safety of Premarin in this patient population.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: Premarin

Study Arms / Comparison Groups

Active Comparator: Premarin once a day
Active Comparator: Premarin 3 times a day

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

April 2010

Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00134654

Responsible Party

William Oh, MD, Dana-Farber Cancer Institute

Study ID Numbers ^ICMJE

02-306

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Faulkner Hospital
Lowell General Hospital
South Shore Hospital
Emerson Hospital
Saint Anne's Hospital

Investigators ^ICMJE

Principal Investigator:

William Oh, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP