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
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

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