s0212 celecoxib in treating patients with high-grade squamous intraepithelial lesions of the cervix

Conditions: Stage 0 Cervical Cancer; High-grade Squamous Intraepithelial Lesion

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.

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.

Eligibility criteria:
disease characteristics: * histologically confirmed high-grade squamous intraepithelial lesions (hgsil) of the cervix * cervical intraepithelial neoplasia (cin) 2 (moderate dysplasia) or cin 3 (severe dysplasia, carcinoma in situ) * must have remaining hgsil after biopsy * no suspicion of invasive cancer by colposcopy within the past 28 days * no invasive or preinvasive high-grade intraepithelial neoplasia by endocervical curettage within the past 56 days patient characteristics: age * 18 and over performance status * zubrod 0-1 life expectancy * not specified hematopoietic * not specified hepatic * sgot and sgpt less than 2.0 times upper limit of normal (uln) * bilirubin less than 2.0 times uln renal * creatinine less than 2.0 mg/dl immunologic * no prior asthma, urticaria, or allergic-type reactions to aspirin or other nsaids * no allergy to sulfonamides * no known sensitivity to celecoxib * no known aids or hiv-associated complex other * not pregnant or nursing * fertile patients must use effective contraception * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage i or ii cancer currently in complete remission prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * no prior pelvic radiotherapy surgery * see disease characteristics other * more than 3 months since prior topical medications for genital condyloma * no prior treatment for squamous intraepithelial lesions * no concurrent topical medications for genital condyloma * no other concurrent treatment * no concurrent chronic (daily for more than 30 days) aspirin * no other concurrent nonsteroidal anti-inflammatory drugs (nsaids)