Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.
详细描述
OBJECTIVES:
- Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel.
- Determine the objective response rate and overall survival of patients treated with these regimens.
- Determine the incidence of thromboembolic events in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
rhuMAB-VEGF
bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.
干预措施: rhuMAB-VEGF (Drug)
rhuMAB-VEGF and Docetaxel
rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle. Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.
干预措施: rhuMAB-VEGF (Drug)
rhuMAB-VEGF and Docetaxel
rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle. Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.
干预措施: docetaxel (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 4 months
次要结局
- Objective Response Rate(56 days)
- Overall Survival(From date of registration until the date of death, assessed up to 5 years)
- Number of Participants With Thromboembolic Events(93 days)