Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
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
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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
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 May 22, 2013