Phase II Trial of Concurrent Irinotecan Plus Cetuximab in Patients With Advanced Breast Cancer With Prior Anthracycline and/or Taxane-Containing Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Confirmed tumor response (complete or partial)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan together with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with cetuximab works in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity, by confirmed response rate, of concurrent irinotecan hydrochloride and cetuximab in patients with metastatic breast cancer with prior anthracycline and/or taxane-containing therapy.
Secondary
- Estimate 6-month, progression-free survival of patients.
- Evaluate the adverse event profile of irinotecan hydrochloride in combination with cetuximab in patients with metastatic breast cancer.
- Estimate progression-free survival of patients.
- Estimate overall survival.
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
cetuximab + irinotecan
Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and irinotecan hydrochloride IV over 1½ hours on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
干预措施: cetuximab (Biological)
cetuximab + irinotecan
Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and irinotecan hydrochloride IV over 1½ hours on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Confirmed tumor response (complete or partial)
时间窗: Up to 5 years
次要结局
- Time to disease progression(Up to 5 years)
- Progression-free survival at 6 months(at 6 months)
- Survival time(Up to 5 years)