NCT00685568已完成1 期
Phase I Pilot Toxicity/Methods Validation Study of Celecoxib in Genotype-Positive Children With Familial Adenomatous Polyposis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.
详细描述
OBJECTIVES:
Primary
- Determine the safety and toxicity of celecoxib in pediatric patients with genotype-positive familial adenomatous polyposis.
Secondary
- Determine the aberrant crypt foci (ACF) and adenoma burden in the entire colorectum of these patients.
- Eliminate the learning curve in a phase II/III trial (reproducibility of endoscopic techniques, tolerability of procedure).
- Compare sedation strategies based on local standards (monitored anesthesia care vs conscious sedation).
- Validate the ACF scoring technique.
- Establish the short-term (3 month) impact of celecoxib on ACF count in order to determine appropriateness of ACF as a pathologic endpoint in a phase II/III trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: celecoxib (Drug)
Arm II
Placebo Comparator
Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Other)
结局指标
主要结局
Toxicity
时间窗: 3 months
次要结局
- Aberrant crypt foci (ACF) and adenoma burden in the entire colorectum(3 months)
- Elimination of the learning curve in a phase II/III trial(3 months)
- Comparison of sedation strategies based on local standards(3 months)
- Validation of technique for scoring ACFs(3 months)
- Short-term (3 month) impact of celecoxib on ACF count(3 months)
- Adherence(3 months)
- Influence of polymorphisms on age of onset of phenotype or on the number of colorectal polyps(3 months)
- Feasibility of psychosocial questionnaires(3 months)
- Pharmacokinetics (plasma drug trough concentrations)(3 months)
研究者
研究点 (4)
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