EUCTR2009-013878-40-DK进行中（未招募）不适用
Phase II trial of Cetuximab in combination with chemotherapy (Carboplatinum and Navelbine) for patients with platinum-resistant head- and neckcancer - CCV-NK
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1. Histological verified planocellular head and neck cancer, where curative intended lokal treatment is not possible.
- •2. Measurable or non-measurable disease.
- •3. Disease progressing during or after first line palliative chemotherapy with cisplatinum or patients recurring after concomittant chemo-radiotherapy with cisplatinum and where treatment is not possible.
- •4. WHO Performance Status 0-2.
- •5. Age = 18 years.
- •6. Neutrophil count (ANC) = 1.5 x 109/l and platelets = 100 x 109/l.
- •7. Normal liver function with bilirubin < 1.5 x UNL (Upper Normal Limit), no UNL for ALAT with liver metastases.
- •8. Creatinin clearence = 30 ml/min (calculated with Cockroft-Gault formular).
- •9. Signed informed consent form.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Other active malignant disease.
- •2. Patients who are considered not able to follow the treatment plan or follow-up visits.
- •3. Other serious disease (eg. severe heart disease, AMI within 1 year, active infection).
- •4. Any condition or treatment which after the opinion of the investigator may expose the patient for a risk or may influence the purpose of the trial.
- •5. Pregnant or lactating women.
- •6. Known hypersensitivity towards one or more of the components of the treatment.
- •7. Prior treatment with either cetuximab or others inhibitors of EGFR during palliative treatment
研究者
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