Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Probability of response (confirmed complete and partial response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent or refractory advanced transitional cell cancer of the urothelium.
详细描述
OBJECTIVES:
- Determine the probability of response (confirmed complete and partial response) to treatment with irinotecan in patients with recurrent or refractory advanced transitional cell carcinoma of the urothelium previously treated with platinum-based chemotherapy.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the overall and progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).
Patients receive irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days 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.
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
Treatment
Irinotecan
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Probability of response (confirmed complete and partial response)
时间窗: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
次要结局
- Number and grade of adverse events(From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years)
- Overall survival(From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years)
- Progression-free survival(From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years)