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

Study Overview
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Brief Summary
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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
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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.

Official Title
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S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

Conditions
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Stage 0 Cervical Cancer, High-grade Squamous Intraepithelial Lesion

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Procedure: anti-cytokine therapy|nan|
|Procedure: antiangiogenesis therapy|nan|
|Procedure: biological therapy|nan|
|Procedure: cancer prevention intervention|nan|
|Procedure: chemoprevention of cancer|nan|
|Procedure: enzyme inhibitor therapy|nan|
|Procedure: growth factor antagonist therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |