Celecoxib for Chemoprevention of Primary Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2
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 lung cancer in tobacco smokers.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.
详细描述
OBJECTIVES:
- Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers.
- Determine the safety and long-term side effects of this drug in this population.
OUTLINE: Patients receive oral celecoxib twice daily for 6 months.
Patients are followed at 2 weeks and then at 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 45
- •Smoked > 20 pack years
排除标准
- •Concurrent use of NSAIDs
- •Hypersensitivity to celecoxib
- •Documented allergic-type reaction to sulfonamides
- •History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs
- •History of liver dysfunction
- •Hypertension or cardiac conditions aggravated by fluid retention and edema
- •Previous history of gastrointestinal ulceration, bleeding, or perforation
- •Renal dysfunction
- •End stage respiratory disease
- •Unstable angina
- •Other malignancy
- •Pregnancy
- •Concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes
- •Patents with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
研究组 & 干预措施
Study
See intervention description.
干预措施: celecoxib (Drug)
结局指标
主要结局
Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2
时间窗: 1 year
Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.
时间窗: 1 year
次要结局
- Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC(2 years)
- Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment(2 years)