Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072540
Status:
WITHDRAWN
Last Update Posted:
2013-11-08
First Post:
2003-11-04
Brief Title:
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S0212 Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
Status:
WITHDRAWN
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
drug issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer Celecoxib may be effective in preventing cervical cancer
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-grade squamous intraepithelial lesions of the cervix
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-grade squamous intraepithelial lesions of the cervix
Detailed Description:
OBJECTIVES
Compare the complete response rate in patients with high-grade squamous intraepithelial lesions of the cervix treated with celecoxib vs placebo
Compare the toxicity of these drugs in these patients
Determine preliminarily the effect of celecoxib on cyclooxygenase-2 expression and human papilloma virus expression in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to high-grade squamous intraepithelial lesion status cervical intraepithelial neoplasia CIN 2 vs CIN 3 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral celecoxib twice daily for 1 month
Arm II Patients receive oral placebo twice daily for 1 month In both arms treatment repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity All patients then undergo loop electrosurgical excision procedure or cone biopsy to determine response
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study within 1-2 years
Compare the complete response rate in patients with high-grade squamous intraepithelial lesions of the cervix treated with celecoxib vs placebo
Compare the toxicity of these drugs in these patients
Determine preliminarily the effect of celecoxib on cyclooxygenase-2 expression and human papilloma virus expression in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to high-grade squamous intraepithelial lesion status cervical intraepithelial neoplasia CIN 2 vs CIN 3 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral celecoxib twice daily for 1 month
Arm II Patients receive oral placebo twice daily for 1 month In both arms treatment repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity All patients then undergo loop electrosurgical excision procedure or cone biopsy to determine response
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| U10CA037429 | NIH | SWOG | httpsreporternihgovquickSearchU10CA037429 |
| S0212 | OTHER | None | None |