JPRN-UMIN000002094已完成2 期
Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type - Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type
Epidemiological and Clinical Research Information Network (ECRIN)0 个研究点目标入组 50 人开始时间: 2009年6月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
Anticancer Res. 2014 Apr;34(4):1967-73. Results:Sixty-seven patients (59.8%) were EGFR-positive and KRAS wild-type. The mean age of the enrolled patients (n=60) was 62.6 years (range=37-82 years). The response rate was 31.7% and stable disease was observed in 53.3%. No objective response was observed in patients with BRAF or PIK3CA mutations. The median PFS and OS were 7.4 and 18.2 months, respectively. Grade-3/4 adverse events were leucopenia (26.7%), neutropenia (43.3%), paronychia (10.0%), fissure (10.0%) and acne-like rash (5.0%).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Severe bone marrow suppression (2)Wattery diarrhea (3)Severe infectious disease (4)Massive pleural effusion or ascites (5)Comorbidity or history of heart failure (6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (7)Paralytic or mechanical bowel obstruction (8)Jaundice (9)Patients who is receiving Atazanavir Sulfate (10)History of severe allergy (11)Pregnant or lactating women or women of childbearing potential (12)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc) (13)Symptomatic brain metastasis (14)Simultaneous or metachronous double cancers (15)Any other cases who are regarded as inadequate for study enrollment by the investigator.
研究者
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