JPRN-UMIN000002182已完成2 期
A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802) - A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)0 个研究点目标入组 41 人开始时间: 2009年7月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
The ORR was 36.6% [95% confidence interval (CI) 22.1-53.1%], median PFS was 9.4 months (95 CI 7.4-17.7 months), and median OS was 24.0 months (95% CI 19.9 months-not reached).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) ECOG PS 3-4 2) with a brain tumor or brain metastasis 3) with double cancer diagnosed within 5 years except for basal cell Carcinoma, CIS of portion, and/or CIS of digestive tract treated curatively 4) with a symptom of neuro-vascular disorder on the brain 5) without surgical treatment, open biopsy, and/or suturing of injury 6) with plans of surgical operation during this regimen 7) with easy bleeding and/or coagulation disorder 8) with a history of thrombosis 9) with an ulcer on the digestive tracts which is uncontrollable 10) with inflammation of abdominal organs 11) with a disorder of the kidney which needs some therapies 12) with an uncontrolled hypertension 13) with a severe allergy to fluorouracil. Levohorinate calcium 14)patients with a lack of enzyme; DPD (dihydropyridine dehydrogenase) or with adverse events due to fluoropyrimidine 15) with an uncontrollable diarrhea 16) with interstitial pneumonia or pulmonary fibrosis 17) patients who need immuno-suppressive medicines after an organ transplantation 18) with an uncontrollable infection 19) pregnant females, nursing mothers, or pregnancy test-positive females 20) males who do not protect against pregnancy 21) patients whose doctor cannot register for this study
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