Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in PGE2 biosynthesis from baseline and at 14 days after discontinuation of a 7-day course of 325 mg ASA per day
研究概览
简要总结
This pilot clinical trial studies low-dose acetylsalicylic acid in treating patients with stage I-III non-small cell lung cancer. Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes in biomarkers that occur during treatment with acetylsalicylic acid
详细描述
PRIMARY OBJECTIVES:
I. To determine whether ASA (acetylsalicylic acid) 325 mg inhibits prostaglandin E2 (PGE2) biosynthesis in patients with early stage non-small cell lung cancer (NSCLC). Cyclooxygenase (COX) catalytic activity will be determined by measuring the metabolite of PGE2, 11alpha-hydroxy-9,12-dioxo-2,3,4,5-tetranor-prostane-1,20 dioic acid (PGE-M) in urine pre- and post-ASA 325 mg as a surrogate of systemic PGE2 biosynthesis.
SECONDARY OBJECTIVES:
I. To determine whether COX-2 protein has a slow turnover in adenocarcinoma of the lung. COX turnover will be determined by measuring urinary PGE-M levels daily for 7 days after discontinuing ASA 325 mg. COX-2 and Prostaglandin expression will also be measured in tumor samples of patients taken at the time of surgery.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Have confirmed (stage IIIb-IV) or recurrent non-small cell lung cancer, adenocarcinoma histology
- •Understand and voluntarily sign an informed consent document prior to any study related assessments or procedures are conducted
- •Anticipated that they will complete all study procedures
- •Ability to swallow pills
- •No aspirin in the last 7 days
排除标准
- •Know allergy to aspirin or other nonsteroidal anti-inflammatory drugs
- •History of allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs, including ibuprofen
- •Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety
研究组 & 干预措施
Prevention (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO for 7 days.
干预措施: acetylsalicylic acid (Drug)
Prevention (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO for 7 days.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Change in PGE2 biosynthesis from baseline and at 14 days after discontinuation of a 7-day course of 325 mg ASA per day
时间窗: 14 days
PGE2 is a product of the COX-2 protein. Measurement of its urinary metabolite PGE-M would indicate the level of systemic biosynthesis of PGE2 and thus inhibition of COX-2 product formation.
次要结局
- Change in PGE-M levels from baseline and daily for 7 days after discontinuation of a 7-day course of 325 mg ASA per day(14 days)
研究者
Leora Horn, MD
Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center