A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 820
- 主要终点
- Overall Survival: Time From Randomization to Death From Any Cause
研究概览
简要总结
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.
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
- •Adult patients, >=18 years of age
- •Metastatic colorectal cancer and disease progression
- •Previously treated with first-line chemotherapy plus Avastin
- •Eastern Cooperative Oncology Group (ECOG) performance status <=2.
排除标准
- •Diagnosis of progression of disease more than 3 months after last Avastin administration
- •First-line patients with progression-free survival in first-line of <3 months
- •Patients receiving less than 3 consecutive months of Avastin in first-line therapy
- •Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
- •Clinically significant cardiovascular disease within 6 months prior to start of study treatment
- •Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol
研究组 & 干预措施
Chemotherapy
Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
干预措施: Chemotherapy (Drug)
Chemotherapy + Bevacizumab
Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
干预措施: Chemotherapy (Drug)
Chemotherapy + Bevacizumab
Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Overall Survival: Time From Randomization to Death From Any Cause
时间窗: within 6.5 years
次要结局
- Participants With Progression Free Survival Event(within 6.5 years)
- Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria(within 6.5 years)
- Response Rate: Participants With Response Status Based on RECIST Criteria(within 6.5 years)
- Overall Survival: Months From Time of First Line Therapy(within approximately 9.6 years)
- Progression Free Survival: Time to Event(within 6.5 years)