Fulvestrant in Treating Patients With Advanced Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00244998|
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : March 8, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: fulvestrant||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||June 2012|
- Drug: fulvestrant
- Prostate-specific antigen (PSA) objective response rate (complete response [CR] or partial response [PR]) [ Time Frame: Monthly ]
- Toxicity [ Time Frame: Every Month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|