NCT00566800Unknown1 期
Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia
Kansas City Veteran Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Erlotinib may keep esophageal cancer from forming in patients with Barrett esophagus by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with Barrett esophagus.
详细描述
OBJECTIVES:
Primary
- To determine if erlotinib hydrochloride can be used as a chemopreventive agent that can cause histologic regression of Barrett esophagus in patients at high risk of developing esophageal cancer associated with high-grade dysplasia.
Secondary
- To assess whether erlotinib hydrochloride can cause molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy in Barrett esophagus with high-grade dysplasia.
- To establish surrogate markers of chemoprevention in Barrett esophagus with high-grade dysplasia.
- To validate the histologic scoring of Barrett dysplasia developed by our group.
- To evaluate toxicities associated with the use of erlotinib hydrochloride in patients with Barrett esophagus associated with high-grade dysplasia.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of Barrett esophagus with high-grade dysplasia
- •Refused surgery or other localized therapy for high-grade dysplasia
- •No invasive esophageal carcinoma
- •PATIENT CHARACTERISTICS:
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin normal
- •AST and ALT < 3 times upper limit of normal (ULN)
- •Alkaline phosphatase < 3 times ULN
- •No uncontrolled medical condition
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 1 week after completion of study treatment
- •Able to swallow tablets or dissolved tablets
- •No known hypersensitivity to erlotinib hydrochloride
- •No symptoms suggestive of malignancy (e.g., weight loss or vomiting)
- •No history of other malignancies
- •No uncontrolled medical or psychiatric condition that would preclude treatment under this clinical trial
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior exposure to erlotinib hydrochloride
- •No concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal therapy
- •No concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride
次要结局
- Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy
- Validation of histologic scoring of Barrett dysplasia
- Toxicity
研究者
研究点 (2)
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