Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, 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. Cetuximab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the progression-free survival of patients with locally advanced or metastatic pancreatic cancer treated with cetuximab, gemcitabine hydrochloride, and oxaliplatin.
Secondary
- Determine the complete response and partial response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
结局指标
主要结局
Progression-free survival
时间窗: The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals
The corresponding progression-free survival curve and cumulative risk of progression as a function of time post treatment initiation will be estimated using the Kaplan-Meier method
次要结局
- Toxicity(Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.)
- Response rate (complete response and partial response)(After every 4th cycle; End of Treatment and Follow-up)
- Duration of response(The time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented)
- Overall survival(Overall survival will also be estimated using the product-limit method of Kaplan-Meier.)
- Time to progression(The time from the start of the treatment until the criteria for disease progression are met)