Phase I Trial With Docetaxel, Oxaliplatin and S1 as First-line Treatment for Patients With Non-resectable Adenocarcinoma of the Esophagus or Gastric
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Median Overall Survival
研究概览
简要总结
The purpose of this study is to determine maximal tolerable dose (MTD) of the combination of docetaxel, oxaliplatin and S1 (DOS) to patients with gastric cancer.
详细描述
The primary aim of this dose-finding study is to determine the maximum tolerated doses of docetaxel, oxaliplatin and S1 given every second (DOS2w) or third (DOS3w) week as first-line treatment in patients with advanced gastro-esophageal cancer. Secondary end points are to evaluate toxicities according to NCI-CTCAE v. 4, response rate, progression-free survival and overall survival
Primary Outcome Measure:
To determine maximum tolerated dose (MTD) for the the combination regimes (DOS2w) and (DOS3w).
The investigators have planned to examine 4 dose levels of (DOS2w) and 3 dose levels of (DOS3w).
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological proven adenocarcinoma of the esophagus or the ventricle (ECV), and which cannot be treated curatively.
- •Age ≥ 18 years.
- •WHO performance status 0-
- •Neutrophils ≥ 1,5 x 109/L and platelets ≥ 100 x 109/L.
- •Bilirubin ≤ 1,5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL.
- •Creatinine-clearance ≥ 60 ml/min.
- •Planned first day of treatment within 8 days after inclusion in the study.
- •Signed consent form.
排除标准
- •No previous treatment with chemotherapy, except for (neo)-adjuvant chemotherapy for adenocarcinoma - treatment should have been completed at least 6 months before entrance in this study.
- •No sensory neuropathy.
- •No previously treatment with docetaxel, oxaliplatin or S
- •No clinical suspicion of brain metastases.
- •No cytotoxic treatment or other experimental treatment within 2 weeks of inclusion in the study.
- •Other serious disease (i.e. heart disease, AMI within 1 year or ongoing infection).
- •No pregnant women or women who are lactating. Patients who are not using contraception.
- •No known DPD-deficiency or known allergy to taxanes or platinum.
- •No signs of physical or mental illness that would prevent absorption of oral treatment.
研究组 & 干预措施
DOS2W Dose level 1A
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
干预措施: DOS2w Dose level 1A (Drug)
DOS2W Dose level 2A
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
干预措施: DOS2w Dose level 2A (Drug)
DOS2W Dose level 3A
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
干预措施: DOS2w Dose level 3A (Drug)
DOS2W Dose level 4A
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
干预措施: DOS2w Dose level 4A (Drug)
DOS3W Dose level 1B
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
干预措施: DOS3w Dose level 1B (Drug)
DOS3W Dose level 2B
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
干预措施: DOS3w Dose level 2B (Drug)
DOS3W Dose level 3B
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
干预措施: DOS3w Dose level 3B (Drug)
结局指标
主要结局
Median Overall Survival
时间窗: Up to 2 years after first administration of DOS
次要结局
未报告次要终点
研究者
Per Pfeiffer
Professor
Odense University Hospital