Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- One-year Progression-free Survival (PFS)
研究概览
简要总结
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.
详细描述
Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
- •Evidence of adequate organ function (such as liver, kidneys, etc.)
排除标准
- •Diagnosis of anal cancer
- •Patients who are candidates for surgery
- •Patients who have received previous treatments
- •Pregnant or lactating women
- •History of chronic disease(s) or other serious medical conditions
研究组 & 干预措施
1
干预措施: Bevacizumab (Drug)
1
干预措施: Oxaliplatin (Drug)
1
干预措施: Capecitabine (Drug)
2
干预措施: Bevacizumab (Drug)
2
干预措施: Capecitabine (Drug)
2
干预措施: Irinotecan (Drug)
结局指标
主要结局
One-year Progression-free Survival (PFS)
时间窗: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
次要结局
- Objective Response Rate(Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.)
- Toxicity - Adverse Events(Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab)
- Overall Survival(Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.)
- Duration of Response(Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.)