Randomized, Phase IIb Trial of Sulindac in Smokers With Bronchial Dysplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment
研究概览
简要总结
This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cancer from forming in patients with bronchial dysplasia. It is not yet known whether sulindac is more effective than a placebo in preventing lung cancer in patients with bronchial dysplasia.
详细描述
PRIMARY OBJECTIVES:
I. Compare the change in histologic grade of bronchial dysplasia, as determined from mucosal biopsy samples obtained during pre- and post-intervention autofluorescence bronchoscopy exams, in current or former smokers with bronchial dysplasia treated with sulindac vs placebo.
SECONDARY OBJECTIVES:
I. Compare the change in number of dysplastic lesions, as determined from mucosal biopsy samples obtained during pre- and post-intervention autofluorescence bronchoscopy exams, in patients treated with these regimens.
II. Compare changes in tissue-based biomarkers (cyclooxygenase [COX]-2, 15-lipoxygenase [LOX]-1, PPAR γ, Ki-67, caspase-3, cyclin D1, cyclin E) in patients treated with these regimens.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or former smoker who has smoked at least 30 pack years AND meets 1 of the following criteria:
- •No prior lung cancer
- •Prior stage I non-small cell lung cancer(NSCLC) that was completely resected ≥ 1 year ago OR for which patient completed adjuvant chemotherapy ≥ 1 year ago
- •Tissue blocks, blood, and sputum samples available for research purposes
- •No carcinoma in situ
- •ECOG performance status 0-1
- •Hemoglobin ≥ 12.0 g/dL (women) or hemoglobin ≥ 13.5 g/dL (men)
- •WBC ≥ 3,000/mm³
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥30 mL/min
- •Room air oxygen saturation ≥ 90%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Negative chest x-ray
- •Negative electrocardiogram
- •No other cancer within the past 3 years except nonmelanoma skin cancer, localized prostate, carcinoma in situ of the cervix cancer, or superficial bladder cancer
- •Treatment must have been completed > 6 months ago
- •No prior gastrointestinal ulceration, bleeding, or perforation
- •No uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Myocardial infarction within the past 6 months
- •Chronic renal disease
- •Chronic liver disease
- •Difficult to control hypertension
- •Psychiatric illness or social situations that would limit study compliance
- •No known HIV positivity
- •No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria
- •No known sensitivity to yellow dye FD&C Yellow #5
- •No continuous or intermittent supplemental oxygen
- •At least 6 months since prior participation in another chemoprevention trial
- •At least 6 months since prior regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (may be eligible after washout period of 12 weeks for NSAIDs and 6 weeks for corticosteroids)
- •No prior pneumonectomy
- •No prior solid organ transplantation
- •No other concurrent investigational agents
- •No concurrent regular use of acetylsalicylic acid (aspirin) unless prescribed by a physician for prevention
- •Maximum of 1 aspirin (81 mg) per day allowed
- •No concurrent use of any of the following:
- •Methotrexate
- •Corticosteroids
- •Antiplatelet agents:
- •Ticlopidine
- •Clopidogrel bisulfate
- •Abciximab
- 另有 8 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral sulindac twice daily for 6 months.
干预措施: sulindac (Drug)
Arm II
Patients receive oral placebo twice daily for 6 months.
干预措施: placebo (Other)
结局指标
主要结局
Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment
时间窗: Baseline and 6 months
Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease
次要结局
- Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention(Baseline and 6 months)