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

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.

Study Type: Interventional

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

Study Primary Completion Date: July 2005

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Group A
  • Premarin once a day
• Active Comparator: Group B
  • Premarin 3 times a day

Primary Measures

• To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer
  • Time Frame: TBD
    Safety Issue?: No

Secondary Measures

• To evaluate the safety of Premarin in this patient population
  • Time Frame: 2 years
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dana-Farber Cancer Institute

Overall Clinical Trial Officials and Contacts

William Oh, MD Principal Investigator Dana-Farber Cancer Institute  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00134654

Study ID Number: 02-306

ClinicalTrials.gov Identifier: NCT00134654

Health Authority: United States: Institutional Review Board