Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081263
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2004-04-07
Brief Title:
Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Double-Blind Phase II Trial of Celecoxib A COX-2 Inhibitor in the Treatment of Patients With Cervical Intraepithelial Neoplasia 23 or 3 CIN 23 or 3
Status:
COMPLETED
Status Verified Date:
2017-08
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:
This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia a precancerous lesion of the cervix which can develop into cervical cancer Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of celecoxib to induce complete remission or partial regression to cervical intraepithelial neoplasia CIN 1 of CIN 23 or CIN 3 as evaluated in the post-treatment excisional biopsy
II To determine the toxicity of celecoxib 400 mg once daily as assessed by Common Terminology Criteria for Adverse Events in this patient population of women with CIN 23 or CIN 3
SECONDARY OBJECTIVES
I To assess whether treatment with celecoxib changes the number of quadrants containing acetowhite lesions as determined through colposcopic examination
II To determine the efficacy of celecoxib treatment in changing human papillomavirus HPV viral load in cervical cells
III To examine the association of histologic response HPV viral load lesion size proliferation index marker of proliferation Ki-67 Ki67 apoptosis index terminal deoxynucleotidyl transferase TdT-mediated dUTP nick end labelin TUNEL assay angiogenesis vascular endothelial growth factor VEGF and cyclooxygenase-2 COX-2 in tissue the amount of VEGF and basic fibroblast growth factor bFGF in serum before and after treatment and the amount of celecoxib present in serum during treatment Cervical cytology karyometry will be assessed as a potential marker for regression IV To determine the feasibility of digital imaging web-based review of histopathology in a Gynecologic Oncology Group GOG study
V To compare the diagnoses of the web-based review of histopathology with the diagnoses of GOGs standard procedure
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral celecoxib once daily for 14-18 weeks
ARM II Patients receive oral placebo once daily for 14-18 weeks
I To determine the efficacy of celecoxib to induce complete remission or partial regression to cervical intraepithelial neoplasia CIN 1 of CIN 23 or CIN 3 as evaluated in the post-treatment excisional biopsy
II To determine the toxicity of celecoxib 400 mg once daily as assessed by Common Terminology Criteria for Adverse Events in this patient population of women with CIN 23 or CIN 3
SECONDARY OBJECTIVES
I To assess whether treatment with celecoxib changes the number of quadrants containing acetowhite lesions as determined through colposcopic examination
II To determine the efficacy of celecoxib treatment in changing human papillomavirus HPV viral load in cervical cells
III To examine the association of histologic response HPV viral load lesion size proliferation index marker of proliferation Ki-67 Ki67 apoptosis index terminal deoxynucleotidyl transferase TdT-mediated dUTP nick end labelin TUNEL assay angiogenesis vascular endothelial growth factor VEGF and cyclooxygenase-2 COX-2 in tissue the amount of VEGF and basic fibroblast growth factor bFGF in serum before and after treatment and the amount of celecoxib present in serum during treatment Cervical cytology karyometry will be assessed as a potential marker for regression IV To determine the feasibility of digital imaging web-based review of histopathology in a Gynecologic Oncology Group GOG study
V To compare the diagnoses of the web-based review of histopathology with the diagnoses of GOGs standard procedure
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral celecoxib once daily for 14-18 weeks
ARM II Patients receive oral placebo once daily for 14-18 weeks
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 |
|---|---|---|---|
| U10CA101165 | NIH | CTEP | httpsreporternihgovquickSearchU10CA101165 |
| NCI-2009-00583 | REGISTRY | None | None |
| CDR0000360805 | None | None | None |
| GOG-0207 | OTHER | None | None |
| GOG-0207 | OTHER | None | None |
| GOG-0207 | OTHER | None | None |