An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Percentage of Participants Achieving Overall Disease Control (ODC)
研究概览
简要总结
This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.
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
- •Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
- •Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.
排除标准
- •Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
- •Untreated brain metastases, spinal cord compression or primary brain tumours;
- •Pregnant or lactating women;
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
- •Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
结局指标
主要结局
Percentage of Participants Achieving Overall Disease Control (ODC)
时间窗: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)
ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.
次要结局
- Progression-Free Survival (PFS) - Percentage of Participants With an Event(Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up))
- Overall Survival (OS) - Percentage of Participants With an Event(Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up))
- OS - Time to Event(Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up))
- Percentage of Participants Achieving a Best Overall Response of CR or PR(Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up))
- Duration of Overall Disease Control(Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up))
- PFS - Time to Event(Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up))
- Duration of Response(Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up))