NCT00055978已完成2 期
Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Modulation of the ki-67 labeling index
研究概览
简要总结
RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer.
详细描述
OBJECTIVES:
- Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer.
- Determine the safety and side effects of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
- Determine the role of COX-2-specific inhibitors (e.g., celecoxib) on antitumor immunity within the lung microenvironment of these patients.
- Determine the effects of COX-2 inhibition on angiogenesis in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to presence of preinvasive lesions (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo twice daily for 6 months.
- Arm II: Patients receive oral celecoxib twice daily for 6 months. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed every 6 months during treatment and then annually for up to 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Heavy former smokers without prior history of NSCLC
- •Age > 45
- •Smoked for minimum of 30 pack years
- •Former smokers with prior curative resection of surgical stage I NSCLC will be recruited and must be:
- •Age > 18
- •Smoked > 10 pack years
- •Must have had pathological staging and the extent of disease documented. At least one nodal station each must have been biopsied and all biopsies must have been negative
- •At least 6 months post curative resection of Stage I prior NSCLC, without evidence for recurrence or second primary lung cancer
- •Normal blood chemistry and cell counts
- •Negative pregnancy test
排除标准
- •Framingham 10-year-risk for coronary artery disease score > 10%
- •History of cardiovascular disease
- •Evidence of diffuse coronary calcification on screening CT
- •Concurrent use of NSAIDs. The use of cardiac (baby) Aspirin is permitted
- •Hypersensitivity to celecoxib, sulfonamides, aspirin or other NSAIDs
- •Liver dysfunction [abnormally elevated liver function tests [transaminases (ALT, AST) > ULN, alkaline phosphatase (ALKP) > 1.5 ULN]] or history of cirrhosis
- •No peptic ulcer disease (PUD) diagnosis nor active symptoms in the last 2 years or, if PUD was diagnosed < 2 years, there must be no active symptoms, and endoscopic confirmation of healing
- •Renal dysfunction [abnormally elevated blood urea nitrogen (BUN) > 1.5 ULN and creatinine > ULN]
- •End state respiratory disease
- •Unstable angina or a history of significant coronary artery disease
- •Other malignancies excluding non-melanoma type skin cancer and in situ cervical cancer. Persons with stage I/II head and neck cancer must be disease free for at least 12 months
- •Pregnancy
- •Lactation
- •Unwillingness to practice contraception
- •On systemic corticoid steroid therapy
- •Coagulopathy
- •Use of Coumadin
- •Concurrent use of medication know to alter or be affected by alteration of hepatic p450 2C9 enzymes.
- •Patients with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
- •Patients who had received photosensitizing agents such as hematoporphyrin derivative or chemopreventive drugs such as retinoids within 3 months prior to the bronchoscopic procedure, radiotherapy to the chest, or cytotoxic chemotherapy agents
- •Subject found to have CIS during screening bronchoscopy will be treated with local therapy prior to randomization
研究组 & 干预措施
Arm I
Experimental
Patients receive oral placebo twice daily for 6 months.
干预措施: placebo (Other)
Arm II
Experimental
Patients receive oral celecoxib twice daily for 6 months.
干预措施: celecoxib (Drug)
结局指标
主要结局
Modulation of the ki-67 labeling index
时间窗: 5 years
Phenotypic modulation of the bronchial histology
时间窗: 5 years
次要结局
- Evidence of molecular/genetic aberrations(5 years)
- Changes indicative of response to treatment in the targeted signaling pathway(5 years)
- Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis(5 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco SmokersLung CancerNCT00020878Jonsson Comprehensive Cancer Center21
撤回
2 期
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the CervixStage 0 Cervical CancerHigh-grade Squamous Intraepithelial LesionNCT00072540SWOG Cancer Research Network
已完成
2 期
Celecoxib in Preventing Head and Neck Cancer in Patients With Oral LeukoplakiaHead and Neck CancerPrecancerous ConditionNCT00101335Fox Chase Cancer Center
终止
3 期
Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon CancerColorectal CancerNCT00087256NSABP Foundation Inc18
已完成
2 期
Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung CancerHead and Neck CancerLung CancerNCT00058006Northwestern University