NCT00206219已完成3 期
A Phase III Randomised, Stratified, Parallel-Group, Multi-Centre, Comparative Study of ZD1839 (Iressa®) 250 Mg and 500 Mg Versus Methotrexate for Previously Treated Patients With Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 477
- 试验地点
- 108
- 主要终点
- Compare ZD1839 versus methotrexate in overall survival
研究概览
简要总结
This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histological confirmation of evidence of squamous cell carcinoma of the head and neck.
- •Tumors have progressed after primary treatment with radiation or chemoradiation and have failed to respond to at least one course of standard platinum-based chemotherapy.
- •Tumors have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy.
排除标准
- •Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors.
- •Isolated recurrent disease that may be amenable to local therapy; e.g., surgical intervention or radiation therapy.
- •Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of these products.
结局指标
主要结局
Compare ZD1839 versus methotrexate in overall survival
次要结局
- Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.
研究者
研究点 (108)
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