NCT01024504已完成2 期
A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
Hellenic Oncology Research Group6 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 6
- 主要终点
- Overall response rate
研究概览
简要总结
This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.
详细描述
Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- •Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
- •Absence or irradiated and stable central nervous system metastatic disease.
- •Life expectancy of more than 3 months.
- •Age ≥ 70 years.
- •Performance status (WHO) ≤
- •Adequate bone marrow function (Absolute neutrophil count >1000/mm3, Platelet count >100000/mm3, Hemoglobin >9gr/mm3).
- •Adequate liver (Bilirubin <1.5 times upper limit of normal and SGOT/SGPT <2 times upper limit of normal).
- •Creatinine clearance (Cockcroft-Gault formula) >30ml/min.
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
- •Presence of a reliable care giver.
- •Informed consent.
排除标准
- •Prior chemotherapy for metastatic disease.
- •History of thromboembolic disease or myocardial infraction within the last 6 months.
- •Peripheral neuropathy ≥ grade
- •Bowel obstruction or chronic diarrhea.
- •Psychiatric illness or social situation that would preclude study compliance.
- •Other concurrent uncontrolled illness.
- •Other concurrent investigational agents.
研究组 & 干预措施
XELOX/Avastin
Experimental
Capecitabine Oxaliplatin Bevacizumab
干预措施: Oxaliplatin (Drug)
XELOX/Avastin
Experimental
Capecitabine Oxaliplatin Bevacizumab
干预措施: Capecitabine (Drug)
XELOX/Avastin
Experimental
Capecitabine Oxaliplatin Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Overall response rate
时间窗: 2 - 4 months
次要结局
- Time to tumor progression(1 year)
- Overall survival(1 year)
- Toxicity profile(Toxicity assessment on each cycle)
研究者
研究点 (6)
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