Stage 0 Cervical Cancer, High-grade Squamous Intraepithelial Lesion
Conditions
Brief 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.
Interventions
DRUGcelecoxib
PROCEDUREanti-cytokine therapy
PROCEDUREantiangiogenesis therapy
PROCEDUREbiological therapy
PROCEDUREcancer prevention intervention
PROCEDUREchemoprevention of cancer
PROCEDUREenzyme inhibitor therapy
PROCEDUREgrowth factor antagonist therapy
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Outcome results
None listed