Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 304
- 主要终点
- Overall Survival at 6 Months
研究概览
简要总结
RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
- Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
- Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis with time to progression, response, overall survival, toxic effects, and time to treatment failure in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration.
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
Cetuximab
250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
干预措施: cetuximab (Biological)
结局指标
主要结局
Overall Survival at 6 Months
时间窗: every 3 weeks while on treatment, then every 3 months
Time to death is measured from date of registration to date of death due to any cause.
次要结局
- Time to Progression(every 3 weeks while on treatment, then every 3 months for 3 years)
- Time to Treatment Failure(every 3 weeks while on treatment)