NCT00125034已完成2 期
Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Best Overall Response Rate - Independent Review Committee (IRC)
研究概览
简要总结
This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.
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
- •First-line mCRC
- •EGFR positive
- •Bi-dimensional measurable index lesion
排除标准
- •Previous exposure to EGFR-targeting therapy
- •Previous oxaliplatin-based therapy
- •Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
- •Radiotherapy
- •Any other investigational drug in the 30 days before randomization
- •Brain metastasis and/or leptomeningeal disease
- •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
研究组 & 干预措施
Cetuximab Plus FOLFOX-4
Experimental
干预措施: Cetuximab (Biological)
FOLFOX-4 Alone
Active Comparator
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Best Overall Response Rate - Independent Review Committee (IRC)
时间窗: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.
次要结局
- Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)(Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007)
- Best Overall Response Rate (KRAS Mutant Population)(Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007)
- Progression-free Survival Time(Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007)
- Progression-free Survival Time (KRAS Wild-Type Population)(Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008)
- Participants With No Residual Tumor After Metastatic Surgery(Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008)
- Progression-free Survival Time (KRAS Mutant Population)(Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008)
- Overall Survival Time(Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008)
- Overall Survival Time (KRAS Wild-Type Population)(Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008)
- Overall Survival Time (KRAS Mutant Population)(Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008)
- Disease Control Rate (Cut Off Date 4 August 2006)(Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006)
- Duration of Response(Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007)
- Safety - Number of Patients Experiencing Any Adverse Event(time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008)
研究者
研究点 (1)
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