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: July 3, 2012
Last verified: July 2012
  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:
  • Efficacy, defined as the first evidence of a total serum PSA decline of >50% from baseline maintained for at least 28 days and confirmed with two consecutive measurements taken two weeks apart [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression, defined as the time from first administration of study drug to the first observation of disease progression [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
  • Disease progression, defined as an increase of >25% over the baseline PSA on two consecutive measurements two weeks apart, need for palliative therapy, or a decline in at least 20% in KPS [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
  • Time to sustained biochemical response, defined as the time from first administration of drug to first evidence of sustained response [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
  • Duration of sustained response, defined as time from PSA decrease of >50% from baseline to the first evidence of disease progression [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]

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)
Intervention Details:
    Drug: Fulvestrant
    im Dose is Day 1 250mg, day 14 250mg, thereafter qmonth 250 mg
    Other Name: 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 to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1. Must give signed written informed consent 2. Must be of age 18 years or older 3. Histologically confirmed adenocarcinoma of the prostate 4. Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy 5. Must have had rise in PSA despite anti-androgen withdrawal 6. Must exhibit two consecutive rises in PSA after the last hormonal manipulation 7. Minimum PSA > 5mg/dL 8. KPS > 80% 9. Up to one prior chemotherapy treatments allowed 10.Life expectancy of greater than 6 months

Exclusion Criteria:1. Concomitant hormonal therapy other than an LHRH 2. Noncompliance 3. Platelets less than 100 x 10^9 /L 4. International normalization ratio (INR) greater than 1.6 5. Total bilirubin greater than 1.5 x ULRR 6. 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 7. History of:

  1. bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
  2. long-term anticoagulant therapy (other than antiplatelet therapy).
  3. 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

No publications provided

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00476645     History of Changes
Other Study ID Numbers: PROS0010, 96025
Study First Received: May 18, 2007
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014