Fulvestrant in Hormone Refractory Prostate Cancer

NCT ID: NCT00476645

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Prostatic Neoplasms; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fulvestrant

Group Type: EXPERIMENTAL

Fulvestrant

Intervention Type: DRUG

Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly

Interventions

Fulvestrant

Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly

Intervention Type: DRUG

Other Intervention Names

Faslodex; ICI 182,780

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sandy Srinivas

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Sandy Srinivas

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

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).

Reference Type: RESULT

Other Identifiers

96025

Identifier Type: OTHER

Identifier Source: secondary_id

PROS0010

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-01890

Identifier Type: -

Identifier Source: org_study_id