A Phase I/II Study of Induction Conatumumab and Gemcitabine, Followed by Conatumumab, Capecitabine and 3-D Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Dose-limiting toxicity (Phase I)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as conatumumab, 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. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy may uses high energy x-rays to kill tumor cells. Giving conatumumab together with gemcitabine hydrochloride, capecitabine, and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of conatumumab when given together with gemcitabine hydrochloride, capecitabine, and radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the maximum tolerated dose of conatumumab up to a target dose of 10 mg/kg given concurrently with capecitabine and radiotherapy following induction therapy comprising conatumumab and gemcitabine hydrochloride in patients with locally advanced pancreatic cancer. (Phase I)
- To evaluate the overall survival of patients treated with this regimen. (Phase II)
Secondary
- To evaluate the safety profile in patients treated with this regimen. (Phase I and II)
- To evaluate the progression-free survival of patients treated with this regimen. (Phase II)
- To evaluate the primary tumor response rate in patients treated with this regimen. (Phase II)
- To generate translational research hypotheses. (Phase II)
研究设计
- 研究类型
- Interventional
- 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
结局指标
主要结局
Dose-limiting toxicity (Phase I)
Overall survival (Phase II)
次要结局
- Adverse events (Phase I and II)
- Progression-free survival (Phase II)
- Response rate (Phase II)
