NCT00954876撤回2 期
Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
研究概览
简要总结
The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Metastatic colorectal cancer
- •Tumor classified WT KRAS
- •At least 18 yrs of age
- •ECOG PS 0,1 or 2
- •Evidence of adequate organ function
- •Measurable disease per RECIST criteria
- •Have at least two of the following criteria:
- •Age > 65 years
- •ECOG PS 1 or 2
- •Serum Albumin < or equal to 3.5g/dL
- •Prior RT to abdomen or pelvis
- •Stopped first-line combination systemic chemotherapy < 6 weeks duration
排除标准
- •Tumors classified as KRAS mutation
- •Prior therapy with cetuximab, panitumumab or other agent that targets EGFR
- •Prior exposure to any biologic
- •Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)
- •Known DPD deficiency
- •Uncontrolled angina or a myocardial infarction within the previous 12 months
- •Concurrent severe uncontrolled medical illness
- •Known uncontrolled CNS metastases
- •Bowel disease associated with chronic diarrhea
- •Major surgery within 28 days
结局指标
主要结局
Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
时间窗: 18 months
次要结局
- To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab(18 months)
- To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.(1 year after study closure)
- To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab(18 months)
- To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population(every three months)
研究者
研究点 (1)
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