Fulvestrant in Treating Patients With Advanced Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00244998
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.

PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with advanced prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine if the prostate-specific antigen objective response (complete and partial response) rate is \> 0.2 in patients with androgen-independent advanced prostate cancer treated with fulvestrant.

Secondary

* Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Courses repeat once a month in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-27
• Primary Completion: 2006-10
• Study Completion: 2012-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prostate-specific antigen (PSA) objective response rate (complete response [CR] or partial response [PR])	Monthly

Secondary Outcome Measures

Name	Time	Method
Toxicity	Every Month

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States