EUCTR2013-002886-20-NL进行中（未招募）不适用
A phase Ib-II study of the combination of cetuximab and methotrexate in recurrent or metastatic squamous cell carcinoma of the head and neck. A study of the Dutch Head and Neck Society. - Cetuximab and MTX in SCCH
MC St Radboud0 个研究点开始时间: 2013年9月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histology and disease stage
- •? Recurrent or metastatic SCCHN.
- •? No prior systemic treatment for recurrent or metastatic disease.
- •? Primary site: oral cavity, oropharynx, hypopharynx or larynx.
- •? Time between prior treatment and inclusion in the study (> 3 months).
- •General conditions
- •? Written informed consent.
- •? WHO performance status 0-2.
- •? Normal number of neutrophils and trombocytes.
- •? Normal hepatic function.
- •? Renal function: calculated creatinin clearance > 60ml/min.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •General conditions
- •? Serious active infections.
- •? Pregnancy or lactation.
- •? Patients (M/F) with reproductive potential not implementing adequate contraceptives measures.
- •Prior history
- •? Prior treatment with EGFR inhibitors or methotrexate.
- •Concomitant treatments
- •? Concomitant (or within 4 weeks before randomization) administration of any other experimental drug under investigation.
- •? Concurrent treatment with any other anti-cancer therapy.
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