JPRN-UMIN000007072已完成2 期
Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer - Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group0 个研究点目标入组 40 人开始时间: 2012年1月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients with pathologically proven colorectal cancer. 2) Patients with unrecectable metastatic colorectal cancer. 3) Patients with confirmed target lesion. 4) Patients with no prior chemotherapy. 5) Patients with no prior radiotherapy. 6) Patients of age =>20 and 75> 7) Patients with expected life for at least 3 month. 8) Performance Status:0-1(ECOG) 9) Sufficient organ functions 1:hemoglobin>=9.0g/dL 2:WBC >=3,500/mm3 and 12000/mm3> 3:neutrophils>=1,500/mm3 4:platelets>=100,000/mm3 5:total bilirubin <=1.5mg/dL 6: ALT AST<=100IU (or <=150IU if liver metastases were present) 7:serum creatinine <= 1.2mg/dL 8:creatinine clearance>=60ml/min 10) Capability of oral intake 11) Normal cardiac function confirmed by cardiac electro gram within 28 days of registration 12) Written informed consent 1) Medical history of severe anaphylaxis or allergia to any drug 2) Patients with active synchronous or metachronous malignancy other than carcinoma in situ 3) Severe infection 4) Perforation of the digestive tract or paralyzed intestinal tract within 1 year of registration 5) Uncontrollable hypertension with medical therapy 6) Severe complication (lung fibrosis or intestinal pneumonia, heart failure, renal failure, hepatic insufficiency, uncontrolled diabetes etc) 7) Massive pleural or abdominal effusion 8) Watery diarrhea 9) Need to treatment with flucytosine or atazanavir sulfate 10) Patients with brain metastases 11) Pregnant or nursing 12) Severe mental illness 13) Systemic administration of corticosteroids 14) Patients with uric protein 2+ 15) Patients with thrombosis 16) Patients with cerebral infarction, cardiac infarction or pulmonary infarction 17) Patients who underwent surgery within 4 weeks 18) Systemic administration of antiplatelet drug 19) Patients with known bleeding disorders or clotting disorder 20) Patients who are judged inappropriate for the entry into the study by the investigator
研究者
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