Trial Search Results

Fulvestrant in Hormone Refractory Prostate Cancer

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: AstraZeneca

Stanford Investigator(s):

Intervention(s):

  • Drug: Fulvestrant

Phase:

Phase 2

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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas
6507361252
Not Recruiting