Phase II Trial Assessing the Impact on the Activity of Daily Living of an Oral Chemotherapy by Capecitabine Associated With an Intravenous Chemotherapy by Oxaliplatin as First Line Treatment of Metastatic Colorectal Adenocarcinoma of Patients Aged Over 70
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as defined by stabilization or improvement by 1 point on Katz's Activities of Daily Living scale, in older patients with metastatic colorectal adenocarcinoma.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the percentage of patients who receive the first 3 courses of this regimen (at lower doses) and the percentage of patients who receive all 6 courses of this regimen (at both lower and higher doses).
- Determine efficacy of this regimen, as defined by RECIST criteria, in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Capecitabine + Oxaliplatin
Patients receive oral capecitabine once daily on days 1-14 and oxaliplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
干预措施: capecitabine (Drug)
Capecitabine + Oxaliplatin
Patients receive oral capecitabine once daily on days 1-14 and oxaliplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale
次要结局
- Efficacy as defined in RECIST criteria
- Toxicity
- Percentage of patients who receive the first 3 treatment courses at a lower dose and the percentage of patients who receive all 6 treatment courses at both lower and higher doses
- Pharmacokinetics