Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

OBJECTIVES:

Primary

- Determine the efficacy of celecoxib, in terms of achieving histologic complete or
partial response, in patients with cervical intraepithelial neoplasia (CIN) 2/3 or 3.

- Determine the toxicity of this drug in these patients.

Secondary

- Determine the effect of this drug on changes in lesion size in these patients.

- Determine the effect of this drug on human papillomavirus (HPV) viral load in these
patients.

- Correlate histologic response, HPV viral load, lesion size, proliferation index,
apoptosis index, angiogenesis (VEGF) and COX-2 in tissue, amount of VEGF and bFGF in
serum, and serum celecoxib levels during treatment in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to lesion size (covering ≤ ½ area of the cervix vs covering > ½
area of the cervix) and degree of cervical intraepithelial neoplasia (CIN) (CIN 2/3 vs CIN
3). 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. Patients undergo
colposcopy at week 8 and between weeks 14 and 18. Between weeks 14 and 18, patients
with evidence of disease also undergo large loop excision of the transformation zone
(cone biopsy) or cervical biopsy and patients with no evidence of disease undergo a
cervical biopsy to confirm the absence of disease on colposcopy.

PROJECTED ACCRUAL: A maximum of 130 patients (39 per treatment arm) will be accrued for this
study within 13 months.