NCT00058006已完成2 期
Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to that of a placebo in preventing disease recurrence in patients with stage I or stage II head and neck cancer or stage I non-small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the rate of new malignancies (recurrences and second primary tumors) in patients with early-stage head and neck cancer or non-small cell lung cancer treated with celecoxib vs placebo.
- Compare the event-free and overall survival of patients treated with this drug vs placebo.
- Determine the toxic effects associated with long-term use of celecoxib in these patients.
- Correlate cyclooxygenase-2 and transforming growth factor (TGF)-beta expression and CYP2C9 and TGF-beta genotypes with the rate of new malignancies and survival of patients treated with this drug vs placebo.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to smoking history (active smokers [including those who quit within 1 year of diagnosis] vs former smokers vs non-smokers), tumor type (lung cancer vs head and neck cancer), and stage (I vs II for head and neck cancer or T1 vs T2 for lung cancer). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 24 months in the absence of disease recurrence or unacceptable toxicity.
Patients are followed every 6 months for 5 years or until disease recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 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:
- •One of the following histologically confirmed diagnoses:
- •Stage I non-small cell lung cancer (NSCLC)
- •No small cell component
- •Stage I-II squamous cell cancer of the head and neck
- •No WHO type II or III nasopharyngeal cancer
- •No sinonasal undifferentiated carcinoma
- •No evidence of disease
- •Must have undergone surgery or radiotherapy with curative intent within the past 4-24 weeks
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count at least 50,000/mm^3
- •Bilirubin normal
- •AST/ALT no greater than 2 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No uncontrolled hypertension
- •No severe congestive heart failure
- •No history of asthma caused by cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No other prior malignancy (including skin cancer and in situ malignancies)
- •No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
- •No prior hypersensitivity reaction to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
- •No other concurrent medical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •No cumulative oral or IV corticosteroid use totalling more than 2 weeks within the past 3 months
- •No concurrent oral steroids for more than 2 consecutive weeks
- •Concurrent inhaled steroids allowed
- •Radiotherapy
- •See Disease Characteristics
- •No prior definitive radiotherapy for stage I NSCLC
- •See Disease Characteristics
- •Prior pneumonectomy or lobectomy with mediastinal lymph node sampling or dissection for stage I NSCLC allowed
- •No prior segmentectomies or wedge resections for stage I NSCLC
- •More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
- •No prior NSAID use within the past 30 days at a frequency of 3 or more times a week for more than 2 weeks
- •No concurrent NSAIDs (including low-dose aspirin)
- •No other concurrent COX-2 inhibitors
- •No concurrent fluconazole
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (8)
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