Fulvestrant in Hormone Refractory Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Fulvestrant in Hormone-refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476645
• Other study ID #: IRB-01890
• Secondary ID: 96025PROS0010
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2007
• Last updated: August 4, 2014
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: August 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	AstraZeneca

Country where clinical trial is conducted

United States, 

References & Publications (1)

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).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA Reduction = 50%	Number of subjects with serum PSA reduction = 50% at 3 months	3 months	Yes
Secondary	PSA Doubling Time	Number of subjects with prolongation of PSA doubling time	3 months	Yes
Secondary	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.	12 months	No

External Links

•   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)