Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 95
- 主要终点
- Progression-free survival rate
研究概览
简要总结
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of cancer of the urinary tract.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have advanced cancer of the urinary tract.
详细描述
OBJECTIVES:
- Determine the 6-month progression-free survival rate of patients with advanced transitional cell carcinoma of the urothelium treated with ZD 1839.
- Determine the overall survival and response (confirmed complete and partial response) in these patients treated with this regimen.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Evaluate the changes in growth factor protein kinase expression before and after treatment and at the time of disease progression in these patients treated with this regimen.
OUTLINE: Patients receive oral ZD 1839 once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.
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
- 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
ZD 1839
干预措施: gefitinib (Drug)
结局指标
主要结局
Progression-free survival rate
时间窗: From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years
次要结局
- Overall survival(From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years)
- Confirmed complete and partial response to ZD 1839(From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years)
- Number and grade of adverse events to ZD 1839(From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years)