The purpose of this study it 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
Androgen-independent prostate cancer Prostate Cancer	Drug: Premarin	Phase II

Further Study Details: 

Primary Outcomes: To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer.
Secondary Outcomes: To evaluate the safety of Premarin in this patient population.
Expected Total Enrollment:  48

• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Documented histologic evidence of prostate cancer.
• Progressive androgen-independent prostate cancer as defined by the 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 < 2x upper limit of normal
• Bilirubin < 2x upper limit of normal
• AST < 2x 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

Massachusetts
      Dana-Farber Cancer Insitute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital, Boston,  Massachusetts,  02115,  United States
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

William Oh, MD,  Principal Investigator,  Dana-Farber Cancer Institute   

Study ID Numbers:  02-306
Last Updated:  August 24, 2005
Record first received:  August 24, 2005
ClinicalTrials.gov Identifier:  NCT00134654
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13