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Fulvestrant in Hormone Refractory Prostate Cancer

Primary Purpose

Prostatic Neoplasms, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fulvestrant
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fulvestrant

Arm Description

Outcomes

Primary Outcome Measures

PSA Reduction ≥ 50%
Number of subjects with serum PSA reduction ≥ 50% at 3 months

Secondary Outcome Measures

PSA Doubling Time
Number of subjects with prolongation of PSA doubling time
Stable Disease After One Year
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.

Full Information

First Posted
May 18, 2007
Last Updated
August 4, 2014
Sponsor
Stanford University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00476645
Brief Title
Fulvestrant in Hormone Refractory Prostate Cancer
Official Title
Fulvestrant in Hormone-refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fulvestrant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex, ICI 182,780
Intervention Description
Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly
Primary Outcome Measure Information:
Title
PSA Reduction ≥ 50%
Description
Number of subjects with serum PSA reduction ≥ 50% at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
PSA Doubling Time
Description
Number of subjects with prolongation of PSA doubling time
Time Frame
3 months
Title
Stable Disease After One Year
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sandy Srinivas
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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).
Results Reference
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Fulvestrant in Hormone Refractory Prostate Cancer

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