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Fulvestrant in Hormone Refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00476645
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : August 5, 2014
Last Update Posted : August 5, 2014
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostatic Neoplasms Prostate Cancer Drug: Fulvestrant Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fulvestrant in Hormone-refractory Prostate Cancer
Study Start Date : September 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. PSA Reduction ≥ 50% [ Time Frame: 3 months ]
    Number of subjects with serum PSA reduction ≥ 50% at 3 months


Secondary Outcome Measures :
  1. PSA Doubling Time [ Time Frame: 3 months ]
    Number of subjects with prolongation of PSA doubling time

  2. Stable Disease After One Year [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476645


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
AstraZeneca
Investigators
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Principal Investigator: Dr. Sandy Srinivas Stanford University
More Information
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Publications of Results:
Srinivas S, Harshman LC, Feldman D. "Effect of fulvestrant on PSA doubling time in patients with castration-resistant prostate cancer (CRPC)." JCO. Annual Meeting, ASCO 2010. 20 May 2010;28(15-suppl)(abs e15112).

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Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00476645    
Other Study ID Numbers: IRB-01890
96025 ( Other Identifier: Stanford University alternate IRB Number )
PROS0010 ( Other Identifier: OnCore )
First Posted: May 22, 2007    Key Record Dates
Results First Posted: August 5, 2014
Last Update Posted: August 5, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Fulvestrant
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs