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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Premarin once a day

Group Type ACTIVE_COMPARATOR

Premarin

Intervention Type DRUG

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

Premarin 3 times a day

Group Type ACTIVE_COMPARATOR

Premarin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No