Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073970
Status:
TERMINATED
Last Update Posted:
2012-05-23
First Post:
2003-12-10
Brief Title:
Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped due to increased cardiovascular risks associated with Celebrex
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase II trial to study the effectiveness of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy
PURPOSE Phase II trial to study the effectiveness of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy
Detailed Description:
OBJECTIVES
Determine the effect of celecoxib on prostate-specific antigen PSA levels in patients with prostate cancer in biochemical relapse after prior definitive radiotherapy or radical prostatectomy
Compare the PSA doubling times in patients treated with this drug vs historical controls
Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA values
Determine the time to clinical recurrence in patients treated with this drug
OUTLINE Patients receive oral celecoxib twice daily Treatment continues for 5 years in the absence of disease progression Patients may continue treatment beyond 5 years at the discretion of the treating physician
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
Determine the effect of celecoxib on prostate-specific antigen PSA levels in patients with prostate cancer in biochemical relapse after prior definitive radiotherapy or radical prostatectomy
Compare the PSA doubling times in patients treated with this drug vs historical controls
Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA values
Determine the time to clinical recurrence in patients treated with this drug
OUTLINE Patients receive oral celecoxib twice daily Treatment continues for 5 years in the absence of disease progression Patients may continue treatment beyond 5 years at the discretion of the treating physician
PROJECTED ACCRUAL A total of 100 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNC-01-SURG-655-ORC | None | None | None |
| CDR0000341468 | OTHER | PDQ number | None |