Clinical trial NCT00134654: Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer
Official title: A Phase II Trial of Two Doses of Conjugated Estrogens (Premarin) in Patients With Androgen-Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Androgen-independent prostate cancer
Premarin
conjugated estrogen
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
name: Brigham and Women's Hospital
name: Lowell General Hospital
name: South Shore Hospital
name: Emerson Hospital, Concord, MA
name: Saint Anne's Hospital
First posted: 2005-08-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer
Secondary outcomes:
measure: To evaluate the safety of Premarin in this patient population
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Insitute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mark Pomerantz, MD
role: PRINCIPAL_INVESTIGATOR
References: