Fulvestrant in Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT00476645
First received: May 18, 2007
Last updated: August 4, 2014
Last verified: August 2014
  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).


Condition Intervention Phase
Prostatic Neoplasms
Prostate Cancer
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fulvestrant in Hormone-refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • PSA Reduction ≥ 50% [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of subjects with serum PSA reduction ≥ 50% at 3 months


Secondary Outcome Measures:
  • PSA Doubling Time [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of subjects with prolongation of PSA doubling time

  • Stable Disease After One Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria.


Enrollment: 10
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fulvestrant Drug: Fulvestrant
Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly
Other Names:
  • Faslodex
  • ICI 182,780

Detailed Description:

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). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476645

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
AstraZeneca
Investigators
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00476645     History of Changes
Other Study ID Numbers: IRB-01890, 96025, PROS0010
Study First Received: May 18, 2007
Results First Received: June 30, 2014
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Fulvestrant
Estradiol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Estrogens
Hormones

ClinicalTrials.gov processed this record on October 01, 2014