NCT00101335已完成2 期
A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may prevent or treat head and neck cancer.
PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to placebo in preventing head and neck cancer in patients with oral leukoplakia.
详细描述
OBJECTIVES:
Primary
- Compare the clinical efficacy of celecoxib vs placebo, in terms of inducing regression of oral leukoplakia lesions, in patients with hyperplastic or dysplastic oral leukoplakia.
Secondary
- Determine the effect of this drug in modulating multiple intermediate biomarkers (e.g., COX-2, PPARγ, or PPARδ) in normal and hyperplastic or dysplastic oral epithelia of these patients.
- Determine the safety of this drug in these patients.
- Determine the cost-effectiveness of this drug as a chemopreventative agent in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
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:
- •Diagnosis of oral leukoplakia with hyperplasia or dysplasia
- •Documented by baseline biopsy of oral lesions suspicious for leukoplakia
- •For patients using dentures over the past 6 months, only lesions located on the ventral-lateral tongue or floor of the mouth are allowed
- •No leukoplakia/hyperplasia secondary to mechanical irritation
- •No carcinoma in situ of the oral cavity
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •At least 1 year
- •Hematopoietic
- •Hemoglobin ≥ 10 g/dL (women) OR ≥ 11 g/dL (men)
- •AST or ALT normal
- •Bilirubin normal
- •Creatinine normal OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No myocardial infarction within the past 12 months
- •No known active ischemic cardiac disease by stress test or echocardiogram
- •Gastrointestinal
- •No history of gastrointestinal hemorrhage
- •No known gastrointestinal ulcers within the past 2 years unless there is documentation of healed lesions by upper endoscopy
- •No active or suspected peptic ulcer disease
- •Negative stool guaiac test
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study treatment
- •No use of snuff or chewing tobacco within the past 2 months
- •No active invasive malignancy within the past 3 years except nonmelanoma skin cancer or in situ carcinomas
- •No clinical evidence of chronic infectious disease
- •No clinical evidence of connective tissue disease
- •No known hypersensitivity (asthma, urticaria, or acute rhinitis induced by NSAIDs) to aspirin or other NSAIDs
- •No known hypersensitivity to sulfonamides
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •At least 6 months since prior chronic or frequent use of systemic glucocorticoids
- •No concurrent chronic or frequent use of systemic glucocorticoids
- •Radiotherapy
- •Not specified
- •Not specified
- •No prior chronic or frequent (> 100 mg per day aspirin equivalent) use of nonsteroidal anti-inflammatory drugs (NSAIDs) for 7 of the past 14 days
- •At least 3 months since prior experimental therapy
- •No concurrent chronic or frequent use of NSAIDs
- •Cardioprotective doses of aspirin ≤ 100 mg daily are allowed
排除标准
- 未提供
研究者
研究点 (2)
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