Dose Determination of Taxotere®, Eloxatin® and Xeloda® (TEX)in Combination With Herceptin® as First-line Treatment for Patients With HER2 Positive Non-resectable Oesophagus, Cardia or Gastric Cancer (ECV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- To determine maximum tolerable dose (MTD) for the combination regime TEX
研究概览
简要总结
The primary aim of this dose-finding study is to determine the maximum tolerated dose of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first-line treatment in patients with HER2-positive advanced gastro-esophageal cancer. Secondary end points are to evaluate progression-free survival and overall survival.
详细描述
Primary aim:
To define the maximum tolerated dose of the combination of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first- line treatment in patients with HER2-positive advanced gastro-esophageal cancer.
Secondary aims:
Estimating response-rate, progression free survival and overall survival
Methods:
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic disease
- •HER2-positive tumor tissue (IHC 3 + or FISH positive)
- •LVEF > 50 % (MUGA scan or echocardiography)
- •Age ≥ 18 years
- •No prior chemotherapy
- •WHO performance status 0-1
- •Life expectancy of at least 3 months
- •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. In case of liver metastases no UNL for ASAT and ALAT
- •Creatinine clearance ≥ 50 ml/min. Calculated with the Cockroft-Gault formula
- •No neuropathy
- •Planned treatment start within 8 days after inclusion
排除标准
- •Patients who cannot complete treatment or evaluation
- •Any condition or treatment which after the opinion of the investigator may expose the patients to a risc or influence the purpose of the study
- •Known hypersensitivity towards any of the study drugs
- •Other malignant disease within the last 5 days, except for non-melanoma skin cancer
- •Other serious disease (e.g. cardiac disease, AMI within 1 year or infection)
- •Pregnant women or nursing women
- •Physical or mental conditions which may prevent absorption of oral treatment
研究组 & 干预措施
Her-TEX
干预措施: Docetaxel (Drug)
Her-TEX
干预措施: Oxaliplatin (Drug)
Her-TEX
干预措施: Capecitabine (Drug)
Her-TEX
干预措施: Trastuzumab (Drug)
结局指标
主要结局
To determine maximum tolerable dose (MTD) for the combination regime TEX
时间窗: 2 years
The investigators have planned to examine 3 dose levels including 3 patients at each level with escalating doses of docetaxel from 42 mg/m² to 60 mg/m² and fixed doses of oxaliplatin (100 mg/m²), capecitabine 625 mg/m² x 2 and trastuzumab 6 mg/kg.
次要结局
- Progression free survival(3 years)
- Survival(4 years)
- Response rate(3 years)
研究者
Per Pfeiffer
Professor
Odense University Hospital