Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Response Rate (Percentage of Participants With Partial or Complete Response)
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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine, oxaliplatin, and bevacizumab.
Secondary
- Assess time to progression (TTP), disease-free survival (DFS), and overall survival (OS) in patients treated with this regimen.
- Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer.
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
- 18 Years 至 —（Adult, 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
Initial Cohort
干预措施: bevacizumab (Biological)
Initial Cohort
干预措施: oxaliplatin (Drug)
Initial Cohort
干预措施: Capecitabine (Drug)
Second cohort
干预措施: bevacizumab (Biological)
Second cohort
干预措施: oxaliplatin (Drug)
Second cohort
干预措施: Capecitabine (Drug)
结局指标
主要结局
Response Rate (Percentage of Participants With Partial or Complete Response)
时间窗: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.
Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression. Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. The definitions were: Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
次要结局
- Disease Free Survival(From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.)
- Time to Progression(From time of treatment until documented progression, assesed up to 60 months.)
- Overall Survival(From time of treatment until death from any cause, assesed up to 60 months.)
- Safety and Tolerability(After all participants went off study drug regimine.)
研究者
Herbert Hurwitz, MD
Associate Professor of Medicine
Duke University