NCT00061815已完成3 期
A Phase 3 Randomized Multicenter Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in Subjects With Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone.
研究概览
简要总结
The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.
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
- •Documented colorectal cancer which is EGFR-positive and is metastatic.
- •Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.
排除标准
- •A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy.
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Known metastases in the central nervous system.
- •Symptomatic sensory or peripheral neuropathy.
- •More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
- •Prior oxaliplatin therapy.
- •Prior cetuximab or other therapy which targets the EGF pathway.
- •Prior chimerized or murine monoclonal antibody therapy.
研究组 & 干预措施
Cetuximab+FOLFOX4
Experimental
- Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion
- Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion
- Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes
干预措施: cetuximab (Biological)
Cetuximab+FOLFOX4
Experimental
- Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion
- Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion
- Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes
干预措施: oxaliplatin (Drug)
Cetuximab+FOLFOX4
Experimental
- Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion
- Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion
- Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes
干预措施: leucovorin (Drug)
Cetuximab+FOLFOX4
Experimental
- Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion
- Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion
- Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes
干预措施: 5-fluorouracil (Drug)
FOLFOX4.
Active Comparator
- Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion.
- Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion.
干预措施: oxaliplatin (Drug)
FOLFOX4.
Active Comparator
- Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion.
- Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion.
干预措施: leucovorin (Drug)
FOLFOX4.
Active Comparator
- Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion.
- Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion.
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone.
时间窗: Every six weeks
次要结局
- Compare the response rates between the two treatment arms.(Every six weeks)
- Compare progression-free survival between the two treatment arms.(Every six weeks)
- Duration of response within each treatment arm.(Every six weeks)
- Time to response within each treatment arm.(Every six weeks)
- Compare the safety profiles between the two treatment arms.(Every six weeks)
- Compare the quality of life (QOL)between the two treatment arms.(Every six weeks)
- Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.(Every six weeks)
研究者
研究点 (1)
Loading locations...
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