An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated metastatic colon or rectal cancer
- •Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment
排除标准
- •Prior chemotherapy for metastatic colon or rectal cancer
- •Planned radiotherapy for underlying disease
- •Central nervous system metastases
- •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
Bevacizumab + Chemotherapy
Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
干预措施: 5-Fluorouracil (Drug)
Bevacizumab + Chemotherapy
Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
干预措施: Bevacizumab (Drug)
Bevacizumab + Chemotherapy
Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
干预措施: Irinotecan (Drug)
Bevacizumab + Chemotherapy
Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: Baseline up to approximately 3 years
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
次要结局
- Percentage of Participants With Disease Progression or Death(Baseline up to approximately 3 years)
- Percentage of Participants Who Died(Baseline up to approximately 3 years)
- Progression-Free Survival Time(Baseline up to approximately 3 years)
- Duration of Survival(Baseline up to approximately 3 years)
- Number of Participants With Best Overall Response(Baseline up to approximately 3 years)
- Mean Direct Medical Cost for Cancer Related Medical Care Utilization(Baseline up to approximately 3 years)