Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.(THERAPY)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Recommended dose of trastuzumab when given with cetuximab (Phase I)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, 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 cetuximab together with trastuzumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when given together with cetuximab and to see how well it works in treating patients with metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.
详细描述
OBJECTIVES:
Primary
- Determine the recommended dose of trastuzumab when given with cetuximab in patients with metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy. (Phase I)
- Evaluate the objective response rate as assessed by RECIST criteria. (Phase II)
Secondary
- Evaluate the safety profile as assessed by NCI CTCAE v3.0.
- Evaluate progression-free survival.
- Evaluate 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, trastuzumab
干预措施: cetuximab (Drug)
cetuximab, trastuzumab
干预措施: trastuzumab (Drug)
结局指标
主要结局
Recommended dose of trastuzumab when given with cetuximab (Phase I)
时间窗: 15 days
From baseline to the end of treatment
Objective response rate as assessed by RECIST criteria (Phase II)
时间窗: Approximately 8 weeks
From baseline to the end of treatment
次要结局
- Overall survival(Approximately 36 months)
- Progression-free survival(Approximately 36 months)