Trials / Withdrawn
WithdrawnNCT00072540
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- SWOG Cancer Research Network · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | celecoxib | |
| PROCEDURE | anti-cytokine therapy | |
| PROCEDURE | antiangiogenesis therapy | |
| PROCEDURE | biological therapy | |
| PROCEDURE | cancer prevention intervention | |
| PROCEDURE | chemoprevention of cancer | |
| PROCEDURE | enzyme inhibitor therapy | |
| PROCEDURE | growth factor antagonist therapy |
Timeline
- First posted
- 2003-11-05
- Last updated
- 2013-11-08
Source: ClinicalTrials.gov record NCT00072540. Inclusion in this directory is not an endorsement.