EUCTR2006-002270-21-DK进行中（未招募）1 期
Phase I/II study of Taxotere® (docetaxel), Eloxatin® (oxaliplatin) and Xeloda® (capecitabine) as first line treatment to patients with non-resectable ventricular cancer and/or distal esophageal cancer - TEX
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histological proven adenocarcinoma of the stomach and/or esophageal gastric junction (distal 2 cm of oesophagus)
- •2. Age = 18 years
- •3. WHO performance status 0-1
- •4. Life expectancy of more than 3 months
- •5. Adequate haematological function: ANC = 1.5 x 109/L, platelets = 100 x 109/L
- •6. Adequate renal and hepatic function: total bilirubin = 1.5 x upper normal limit, ASAT and/or ALAT = 3 x upper normal limit, no upper limit in case of liver metastases
- •7. Creatinine clearance = 30 ml/min.
- •8. First treatment day planned within 8 days after randomization
- •9. Written informed consent prior to randomization
- •Same as phase I AND
- •1. Measurable lesion according to RECIST
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Phase I and II:
- •1. Prior chemotherapy > 6 months before inclusion
- •2. Neuropathy
- •3. Prior treatment with Taxotere, Oxaliplatin or Xeloda
- •4. Past or concurrent history of malignant neoplasm except for non-melanoma skin cancer
- •5. Evidence of brain metastases
- •6. Concomitant administration of any other experimental drug or within 14 days before inclusion
- •7. Other serious illness or medical conditions (e.g.: myocardial infarction, infection)
- •8. Pregnant or lactating women
- •9. Known allergy towards taxanes, 5-FU or platinum
- •10. Patients who cannot take oral medication
研究者
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