Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 159
- 主要终点
- Confirmed tumor response as measured by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate, in patients with refractory metastatic breast cancer.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
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 120 Years（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
docetaxel + irinotecan
Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 2 months until disease progression and then every 6 months thereafter.
干预措施: docetaxel (Drug)
docetaxel + irinotecan
Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 2 months until disease progression and then every 6 months thereafter.
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Confirmed tumor response as measured by RECIST criteria
时间窗: Up to 5 years
次要结局
- Overall survival(Up to 5 years)
- Distribution of progression times(Up to 5 years)