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

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Beth Israel Deaconess Medical Center Massachusetts General Hospital Faulkner Hospital Lowell General Hospital South Shore Hospital Emerson Hospital Saint Anne's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00134654

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

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
Estimated Study Completion Date:	April 2010
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator 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.
Group B: Active Comparator 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

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

Faulkner 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:	Dana-Farber Cancer Institute ( Mark Pomerantz, MD )
Study ID Numbers:	02-306
Study First Received:	August 24, 2005
Last Updated:	December 7, 2009
ClinicalTrials.gov Identifier:	NCT00134654 History of Changes
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:

Estrogens
Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male

Hormones
Pharmacologic Actions
Neoplasms
Estrogens, Conjugated (USP)
Neoplasms by Site
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on February 08, 2010