A Phase I/II Trial of Concurrent Chemotherapy and ZD1839 (IRESSA) With Hyperfractionated Radiation Therapy, Followed by Maintenance ZD1839 (IRESSA) for Patients With Locally Advanced Squamous Cell Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin, fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Explore the activity of cisplatin, fluorouracil, gefitinib, and hyperfractionated radiotherapy, in terms of 1-year survival and 1-year distant metastatic disease control, in patients with locally advanced squamous cell carcinoma of the head and neck.
Secondary
- Explore the activity of this regimen, in terms of disease-specific survival and local control, in these patients.
- Assess the toxicity of this regimen in these patients.
- Assess the complete response rate in patients treated with this regimen.
- Assess the toxicity and tolerability of long-term maintenance with gefitinib in patients rendered disease free after this treatment regimen.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Concurrent Chemotherapy and ZD1839
干预措施: cisplatin (Drug)
Concurrent Chemotherapy and ZD1839
干预措施: fluorouracil (Drug)
Concurrent Chemotherapy and ZD1839
干预措施: Iressa (Drug)
Concurrent Chemotherapy and ZD1839
干预措施: hyperfractionated radiation therapy (Radiation)
结局指标
主要结局
Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival
时间窗: at 1 year after start of treatment
To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival
Number of Participants With No Distant Metastatic Disease at 1 Year
时间窗: 1 year
1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.
次要结局
- Number of Participants With No Local Disease at 1 Year(at 1 year after start of treatment)
- Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity(at 1 year after start of treatment)
- Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.(3 years)
- Number of Participants Who Completed 2 Years of Therapy(at 2 years after start of treatment)
研究者
David Adelstein
Principal Investigator
Case Comprehensive Cancer Center