NCT00244998

Fulvestrant in Treating Patients With Advanced Prostate Cancer

Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	fulvestrant	IM

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-10-01
• Completion: 2012-06-01
• First posted: 2005-10-27
• Last updated: 2013-03-08

Locations

1 site across 1 country: United States