Erlotinib in Treating Patients With Barrett Esophagus
Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia
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.
研究概览
详细说明
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.
OUTLINE: Patients receive oral erlotinib hydrochloride once daily for 3 months. Patients showing no evidence of progression to cancer by esophagogastroduodenoscopy (EGD) with biopsy receive an additional 3 months of treatment. All patients then undergo repeat EGD, biopsy, and determination of molecular markers (i.e., EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy).
After completion of study treatment, patients are followed for 30 days.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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Missouri
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Kansas City、Missouri、美国、64128
- 招聘中
- Veterans Affairs Medical Center - Kansas City
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接触：
- Joaquina C. Baranda, MD
- 电话号码：816-861-4700 ext 6708
- 邮箱：joaquina.baranda2@med.va.gov
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
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Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride
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次要结果测量
结果测量 |
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毒性
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Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy
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Validation of histologic scoring of Barrett dysplasia
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合作者和调查者
调查人员
- 首席研究员：Joaquina C. Baranda, MD、Kansas City Veteran Affairs Medical Center
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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