NCT00239304已完成1 期
A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Parts 1 and 2: Safety (Incidence of DLTs)
研究概览
简要总结
To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically confirmed head and neck cancer
- •Lymph node negative or positive
- •Metastasis negative
- •Chemo- and radiotherapy naïve
- •Measurable disease by RECIST
- •Written informed consent
排除标准
- •Severe alcohol abuse
- •Active ILD
- •Co-existing chronic gastrointestinal disease(s)
- •Brain metastasis
结局指标
主要结局
Parts 1 and 2: Safety (Incidence of DLTs)
Part 3: Safety and tolerability
次要结局
- Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
- Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels
研究者
研究点 (1)
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