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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