Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244998
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2005-10-25
Brief Title:
Fulvestrant in Treating Patients With Advanced Prostate Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Phase II Study of Fulvestrant Faslodex in Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 02 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
Primary
Determine if the prostate-specific antigen objective response complete and partial response rate is 02 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None