A Phase II Stdy of ZD 1839 in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 11
- 主要终点
- Early response rates of ZD1839 in head and neck tumors
研究概览
简要总结
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of head and neck cancer.
PURPOSE: Phase II trial to study the effectiveness of ZD1839 in treating patients who have metastatic or recurrent cancer of the head and neck.
详细描述
OBJECTIVES: I. Determine the activity of ZD 1839 in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. II. Determine the effectiveness of this regimen in these patients. III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 1-2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Daily administration of ZD1839
干预措施: ZD1839 (Drug)
结局指标
主要结局
Early response rates of ZD1839 in head and neck tumors
时间窗: 2 months
次要结局
未报告次要终点