NCT01830647已完成不适用
Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 18 years of age
- •Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases
- •At least one measurable metastatic lesion (as per RECIST criteria)
- •Life expectancy of > 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate hematological, renal and liver function
排除标准
- •Prior chemotherapy for metastatic disease
- •Clinically significant cardiovascular disease
- •Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose for gastrointestinal ulceration
- •Participation in an investigational trial in the previous 3 months
- •Pregnant or lactating women
- •History of thrombotic or haemorrhagic disorders
- •Evidence of bleeding diathesis or coagulopathy
- •Uncontrolled hypertension
- •Known hypersensitivity to Avastin and any of its excipients, or any of the chemotherapies
- •Evidence of any disease or disorder that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 3.5 years
次要结局
- Efficacy: Time to disease progression(approximately 3.5 years)
研究者
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