Fulvestrant in Treating Patients With Advanced Prostate Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer|
- Prostate-specific antigen (PSA) objective response rate (complete response [CR] or partial response [PR]) [ Time Frame: Monthly ]
- Toxicity [ Time Frame: Every Month ]
|Study Start Date:||September 2005|
|Study Completion Date:||June 2012|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244998
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Donald L. Trump, MD||Roswell Park Cancer Institute|