A Randomized, Open-label Study Comparing the Effect of 3 Chemotherapy Regimens Containing Avastin on Time to Disease Progression in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 306
- 主要终点
- Percentage of Participants With Disease Progression or Death
研究概览
简要总结
A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.
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;
- •colon or rectal cancer, with metastases;
- •>=1 measurable lesion.
排除标准
- •previous systemic treatment for advanced disease;
- •radiotherapy to any site within 4 weeks before study;
- •daily aspirin (>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration;
- •co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).
研究组 & 干预措施
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
干预措施: Bevacizumab [Avastin] (Drug)
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
干预措施: Capecitabine (Drug)
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
干预措施: Irinotecan (Drug)
Bevacizumab + Capecitabine (1250 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
干预措施: Bevacizumab [Avastin] (Drug)
Bevacizumab + Capecitabine (1250 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
干预措施: Capecitabine (Drug)
Bevacizumab + Capecitabine (650 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
干预措施: Bevacizumab [Avastin] (Drug)
Bevacizumab + Capecitabine (650 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Percentage of Participants With Disease Progression or Death
时间窗: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.
Time to Progression (TTP)
时间窗: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.
次要结局
- Overall Survival(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Percentage of Participants With a Best Overall Response of CR or PR(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Time to Treatment Failure(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Percentage of Participants With Progression Excluding Deaths(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Percentage of Participants With Stable Disease(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Duration of Stable Disease (SD)(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Percentage of Participants Who Died(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Percentage of Participants With Treatment Failure(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Time to Progression Excluding Deaths(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Time to Progression Excluding Deaths Not Related to Underlying Cancer(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Percentage of Participants by Best Overall Response(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment(Randomization, Weeks 3, 6 and 9, and 12)
- Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Duration of Overall Response(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death)
- Duration of Overall Complete Response(Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years)