A Phase II Study of Gemcitabine, Oxaliplatin and Bevacizumab Followed by 5-Fluorouracil, Oxaliplatin, Bevacizumab and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Response rate pre-radiation chemotherapy and bevacizumab and after 5-6 weeks of concurrent chemoradiotherapy and bevacizumab
研究概览
简要总结
RATIONALE: 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. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with combination chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: The phase II trial is studying the side effects and how well giving bevacizumab together with gemcitabine, oxaliplatin, fluorouracil, and radiation therapy works in treating patients undergoing surgery for locally advanced pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- To describe the toxicity of bevacizumab with gemcitabine and oxaliplatin, when therapy is given before chemoradiotherapy, in patients with locally advanced pancreatic cancer.
- To describe the toxicity of bevacizumab with oxaliplatin, fluorouracil, and concomitant radiotherapy in these patients.
- To define progression-free survival, time to progression, and overall survival of patients treated with this regimen.
Second
- To determine the percentage of potentially resectable patients who are ultimately able to proceed to successful resection.
- To determine the relationship between markers of apoptosis in tumor cells (including MIF, CREB, HIF-1-alpha expression/polymorphism, and others) and response to therapy.
- To define response rates in 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
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: bevacizumab (Biological)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: fluorouracil (Drug)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: gemcitabine hydrochloride (Drug)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: oxaliplatin (Drug)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: immunohistochemistry staining method (Other)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: laboratory biomarker analysis (Other)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: conventional surgery (Procedure)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: endoscopic biopsy (Procedure)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: laparoscopy (Procedure)
GemOx and Bev, then chemoradiation, then surgery
Gemcitabine 1000 mg/m2 over 100 min on day 1 every 2 weeks
Oxaliplatin 85 mg/m2 over 2 hours on day 2 every 2 weeks
Bevacizumab 10 mg/kg over 90 minutes on day 1 every 2 weeks. Infusion duration may be shortened in subsequent courses if tolerated.
One cycle is 2 weeks. Chemoradiation to begin prior to 4 weeks from last dose of Gem. Between 4 and 6 weeks following chemoradiotherapy, patients will undergo re-staging with CT or MRI and CA 19-9. If there is no evidence of disease progression, the patient will be referred to the surgeon for re-evaluation and consideration of surgical intervention
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Response rate pre-radiation chemotherapy and bevacizumab and after 5-6 weeks of concurrent chemoradiotherapy and bevacizumab
时间窗: after 6-12 weeks
Response rate pre-radiation chemotherapy and bevacizumab and after 5-6 weeks of concurrent chemoradiotherapy and bevacizumab
Progression-free survival
时间窗: approximately 26 weeks
to be assessed after completion of treatment
次要结局
- Percentage of potentially resectable patients who are able to proceed to successful resection(approximately 12 weeks from initial chemo start)