NCT00072540撤回2 期
S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •SGOT and SGPT less than 2.0 times upper limit of normal (ULN)
- •Bilirubin less than 2.0 times ULN
- •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
- •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
- •See Disease Characteristics
- •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)
排除标准
- 未提供
研究者
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