Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217464
Status:
TERMINATED
Last Update Posted:
2015-04-16
First Post:
2005-09-20
Brief Title:
Fulvestrant in Treating Patients With Recurrent Prostate Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Multicenter Study of Fulvestrant Faslodex in Early Recurrent Prostate Cancer Following Local Therapy A Phase II Trial
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed for futility
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 recurrent prostate cancer
PURPOSE This phase II trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether fulvestrant can slow the rise of prostrate-specific antigen PSA level in patients with early recurrent adenocarcinoma of the prostate after radical prostatectomy or irradiation
Secondary
Determine the utility of monitoring serum PSA in patients treated with this drug
Determine the safety of this drug in these patients
Determine changes in bone mineral density and markers of bone resorption in patients with PSA-only failure treated with this drug
OUTLINE This is an open-label single group assignment study
Patients receive fulvestrant intramuscularly on days 0 14 and 28 Treatment repeats once a month in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study for 84 months
Primary
Determine whether fulvestrant can slow the rise of prostrate-specific antigen PSA level in patients with early recurrent adenocarcinoma of the prostate after radical prostatectomy or irradiation
Secondary
Determine the utility of monitoring serum PSA in patients treated with this drug
Determine the safety of this drug in these patients
Determine changes in bone mineral density and markers of bone resorption in patients with PSA-only failure treated with this drug
OUTLINE This is an open-label single group assignment study
Patients receive fulvestrant intramuscularly on days 0 14 and 28 Treatment repeats once a month in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study for 84 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZENECA-IRUSFULV0026 | None | None | None |
| RPCI-I-17203 | None | None | None |