Safety assessment of treatment with bevacizumab in metastatic colorectal cancer: an observational study

Institute of Oncology Ljubljana (Slovenia)0 个研究点目标入组 250 人开始时间: 2010年11月9日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Written informed consent
•2. Histologically confirmed colorectal cancer
•3. Diagnosis of metastatic disease
•4. Aged 18 to 75 years, either sex
•5. Eastern Cooperative Oncology Group (ECOG) performance score 0 - 2
•6. Life expectancy of at least 3 months
•7. Adequate haematological function (absolute neutrophil count [ANC] greater than or equal to 1.5 x 10^9 L, platelets greater than or equal to 100 x 10^9 L, haemoglobin [Hb] greater than or equal to 90 g/L)
•8. Adequate liver function (serum bilirubin less than or equal to 1.5 x upper limit of normal [ULN], aspartate aminotransferase [AST]/alkaline phosphatase [ALP] less than or equal to 2.5 x ULN, in case of liver metastases less than 5 x ULN)
•9. Adequate renal function (calculated creatinine clearance greater than or equal to 50 mL/min)

•1. ECOG performance score greater than 2
•2. Participation in another clinical trial within 30 days prior to entering this study
•3. Known hypersensitivity to any of the study drugs
•4. Clinically significant cardiovascular disease (myocardial infarction less than or equal to 6 months before treatment start, unstable angina, uncontrolled hypertension, arrhythmia requiring medication)
•5. Known coagulopathy
•6. Proteinuria greater than 500 mg/24 hours
•7. Chronic use of full dose oral or parenteral anticoagulants
•8. High dose of aspirin (greater than 325 mg/day)
•9. Anti-platelet drugs or known bleeding diathesis
•10. Psychiatric disability to be clinically significant precluding informed consent
•11. Evidence of any other disease
•12. Metabolic dysfunction or laboratory findings that give a suspicion of a disease or condition that contraindicates the use of any investigational drugs or means a higher risk for treatment-related complications

发起方

Institute of Oncology Ljubljana (Slovenia)