S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

SWOG Cancer Research Network

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Stage 0 Cervical Cancer High-grade Squamous Intraepithelial Lesion

Interventions

celecoxibDRUG

anti-cytokine therapyPROCEDURE

antiangiogenesis therapyPROCEDURE

biological therapyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.