©2024 Stanford Medicine
Fulvestrant in Hormone Refractory Prostate Cancer
Not Recruiting
Trial ID: NCT00476645
Purpose
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).
Official Title
Fulvestrant in Hormone-refractory Prostate Cancer
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
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)
Intervention(s):
drug: Fulvestrant
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
6507361252