Multicenter Randomized Phase II Trial of Docetaxel With/Without VANDETANIB for Advanced Gastroesophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given together with or without vandetanib.
PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works compared with docetaxel given together with vandetanib in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
Primary
- To test the hypothesis that the addition of a targeted agent, such as vandetanib, to standard chemotherapy with docetaxel will result in incremental responses in patients with metastatic gastric or gastroesophageal junction cancer.
Secondary
- To assess progression-free survival and overall survival of patients treated with this regimen.
- To study the toxicity profile of this regimen in these patients.
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 75 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
Arm I
Patients receive docetaxel IV once every 3 weeks.
干预措施: docetaxel (Drug)
Arm II
Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
干预措施: docetaxel (Drug)
Arm II
Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
干预措施: vandetanib (Drug)
Arm III
Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
干预措施: docetaxel (Drug)
Arm III
Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
干预措施: vandetanib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 1 year
次要结局
- Progression-free Survival(3 years)
- Overall Survival(3 years)
- Toxicity(1 year)