Fulvestrant in Hormone Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: AstraZeneca
• Treatments: Estradiol; Fulvestrant; Hormones

Criteria

Inclusion Criteria:

• Must give signed written informed consent

• Must be of age 18 years or older

• Histologically confirmed adenocarcinoma of the prostate

• Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy

• Must have had rise in PSA despite anti-androgen withdrawal

• Must exhibit two consecutive rises in PSA after the last hormonal manipulation

• Minimum PSA > 5mg/dL

• KPS > 80%

• Up to one prior chemotherapy treatments allowed

• Life expectancy of greater than 6 months

Exclusion Criteria:

• Concomitant hormonal therapy other than an LHRH

• Noncompliance

• Platelets less than 100 x 10e9 /L

• International normalization ratio (INR) greater than 1.6

• Total bilirubin greater than 1.5 x ULRR

• ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases

• History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency)

• History of long-term anticoagulant therapy (other than antiplatelet therapy)

• History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)