A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.
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
- •Histologically documented colorectal cancer plus one of the following:
- •Failure of one prior irinotecan- or oxaliplatin-containing regimen, or
- •Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.
排除标准
- •Prior treatment in first line metastatic setting with more than one regimen
- •Prior irradiation of more than 25% of bone marrow.
研究组 & 干预措施
A
AG-013736 (axitinib)
干预措施: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]) (Drug)
D
bevacizumab (avastin)
干预措施: Bevacizumab (avastin) (Drug)
D
bevacizumab (avastin)
干预措施: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) (Drug)
B
Bevacizumab (avastin)
干预措施: Bevacizumab (avastin) (Drug)
B
Bevacizumab (avastin)
干预措施: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]) (Drug)
C
AG-013736 (axitinib)
干预措施: AG-013736 (axitinib) (Drug)
C
AG-013736 (axitinib)
干预措施: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) (Drug)
A
AG-013736 (axitinib)
干预措施: AG-013736 (axitinib) (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks
Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
次要结局
- Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal(Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal)
- Overall Survival (OS)(Baseline until death or up to 1 year after the randomization of last participant)
- Percentage of Participants With Objective Response (OR)(Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks)
- Duration of Response (DR)(Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks)
- Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal(Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal)