JPRN-UMIN000004219已完成2 期
Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated. - KOBE BBP(bevacizumab beyond progression) study
Hyogo Cancer Center, Dept. of Gastrointestinal and Hepatobiliary Oncology0 个研究点目标入组 40 人开始时间: 2010年9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.clinical or radiological evidence of CNS metastases 2.current or previous (at least once within the last 1 year/ twice or more) history of arterial thromboembolism such as cerebrovascular disease 3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to enrollment/ fine-needle aspiration cytology within 7 days prior to enrollment 4.serious non-healing fracture 5.current or previous (within the last 1 year) history of GI perforation 6.evidence of bleeding diathesis, coagulopathy or abnormal coagulation factor (PT-INR>=1.5 within 14 days prior to enrollment) 7.current or recent (within 10 days prior to enrollment) ongoing treatment with anticoagulants for therapeutic purposes 8.ongoing treatment with aspirin (>= 325 mg/day), nonsteroid anti-inflammatory drug or adrenocortical steroid 9.clinically significant (i.e. active) cardiovascular disease (NCI-CTCAE grade 2 or worse), or past or current history (at least once within the last 1 year/ twice or more) of myocardial infarction 10.renal failure need to treat 11.serious complication (uncontrolled ulcer, hypertension, diabetes mellitus, infection, diarrhea,etc) 12.uncontrolled pleural effusion and/or ascites 13.past or current history (within the last 5 years) of malignant disease, except for the early cancer healed clearly 14.interstitial lung disease, or pulmonary fibrosis 15.history of organ transplantation 16.pregnancy, lactation and positive serum pregnancy test/no birth-control 17.serious drug hypersensitivity or history of drug allergy of 5-FU, l-LV and/or irinotecan 18.history of adverse reaction to fluorouracil in which DPD deficiency is suspected 19.any other cases who are regarded as inadequate for trial enrollment by the investigator
研究者
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