Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 6-month progression-free survival
研究概览
简要总结
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether sunitinib malate is effective as maintenance therapy in delaying tumor progression in patients with metastatic pancreatic cancer who are progression-free after 6 months of induction chemotherapy.
PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy to see how well it works compared with observation in avoiding tumor progression after induction chemotherapy in patients with metastatic pancreatic cancer.
详细描述
OBJECTIVES:
- Compare the 6-month progression-free survival of patients with metastatic pancreatic cancer without progression after 6 months of induction chemotherapy treated with sunitinib malate as maintenance therapy vs observation.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive oral sunitinib malate once daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only.
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
sunitinib
sunitinib until progression or for a maximum of 6 months
干预措施: sunitinib (Drug)
结局指标
主要结局
6-month progression-free survival
时间窗: every 2 months during therapy; every 3 months thereafter
CT scan
次要结局
- OVERALL SURVIVAL(monthly)
- PROGRESSION-FREE SURVIVAL(every 2 months during therapy; every 3 months thereafter)
- pharmacodynamics(baseline and every 2 months until progression)
- Response rate(every 2 months during therapy; every 3 months thereafter)
- Toxicity(monthly during therapy)
- endothelial circulating cells(baseline + every 2 months during therapy until progression)
- pharmacogenomics(baseline)
- pharmacokynetics(after 2 months of therapy)