Phase I Study of Chemoprevention With Green Tea Polyphenon E (PPE) and the Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) in Patients With Premalignant Lesions of the Head and Neck
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD) of erlotinib when administered with a constant dose of green tea polyphenon E (PPE).
研究概览
简要总结
The purpose of this study is to test the preventive effects of a combination of drugs: polyphenon E (PPE) derived from green tea extracts, and erlotinib. Because this combination of drugs has not been tested in humans before for the prevention of cancer, it is not clear which dose of each agent will be optimal in combination.
We will test the safety of the combination of PPE and erlotinib and see what effects (good and/or bad) it has on the patient's premalignant lesion, and find the highest dose of each agent that can be given in combination without causing severe side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erlotinib and Green Tea Polyphenon E
Patients will receive erlotinib, at pre-defined dose level, with polyphenon E.
干预措施: Erlotinib (Drug)
Erlotinib and Green Tea Polyphenon E
Patients will receive erlotinib, at pre-defined dose level, with polyphenon E.
干预措施: Green Tea Polyphenon E (Dietary Supplement)
结局指标
主要结局
Maximum tolerated dose (MTD) of erlotinib when administered with a constant dose of green tea polyphenon E (PPE).
时间窗: Cytobrush/biopsy at three months
Define MTD as the dose level of erlotinib when administered with a constant dose of 200 mg (EGCG) TID of Green Tea Polyphenon E (PPE) to a patient results in a probability equal to θ = 0.33 that a dose-limiting toxicity (DLT) will be manifest within 1 cycle defined as 28 days.
次要结局
- To assess the safety of the combination of PPE and erlotinib in patients receiving 3 different doses of erlotinib (50 mg, 75 mg, and 100 mg) in combination with PPE (200 mg EGCG TID) for 6 months.(Baseline, 3, 6, and 12 months)
研究者
Dong Shin
Principal Investigator
Emory University