A Phase II Trial of Weekly Gemcitabine Hydrochloride and Bevacizumab in Combination With Abdominal Radiation Therapy in Patients With Localized Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, 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 bevacizumab, 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. Bevacizumab may also stop the tumor growth by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Gemcitabine and bevacizumab may make tumor cells more sensitive to radiation therapy. Giving gemcitabine together with bevacizumab and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with bevacizumab and abdominal radiation therapy works in treating patients with localized pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients treated with concurrent bevacizumab, gemcitabine hydrochloride, and abdominal radiotherapy.
Secondary
- Determine the quantitative toxicity associated with the delivery of this regimen in these patients.
- Determine the 1-year and median survival of patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the patterns of recurrence in the entire population of patients treated with this regimen and in the subgroup that is resected for cure.
- Determine the safety of this regimen in these patients.
- Evaluate the surgical experience of patients who undergo surgical resection after completion of protocol-directed therapy.
- Evaluate the toxicity associated with surgical resection in these patients.
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
Treatment Arm
Concurrent gemcitabine, bevacizumab, and radiation therapy
干预措施: bevacizumab (Biological)
Treatment Arm
Concurrent gemcitabine, bevacizumab, and radiation therapy
干预措施: gemcitabine (Drug)
Treatment Arm
Concurrent gemcitabine, bevacizumab, and radiation therapy
干预措施: conventional surgery (Procedure)
Treatment Arm
Concurrent gemcitabine, bevacizumab, and radiation therapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Response rate
时间窗: After 10 weeks of concurrent therapy
Response will be measured by CT scans using Recist and defined as Complete Response, Partial Response, Stable disease/no response, Progressive Disease.
次要结局
- Toxicity profile of bevacizumab and gemcitabine with radiation therapy(After every cycle of therapy (cycle = 3-4 weeks), then every 3 months for 2 years, then every 6 months for 3 years, then yearly up to 10 years or until disease progression.)