Dose determination of Taxotere®, Eloxatin® and Xeloda® (TEX) in combination with Herpectin® as first line treatment to patients with HER2-positive non-resectable esophagus, cardia or gastric cancer - Her-Tex

Odense University Hospital0 个研究点目标入组 15 人开始时间: 2010年12月6日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•1. patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic disease
•2. HER2-positive tumor tissue (IHC 3 + or FISH positive)
•3. LVEF > 50 % (MUGA scan or eccocardiography)
•4. Age = 18 years
•5. No prior chemotherapy
•6. WHO performance status 0-1
•7. Lifeexpectancy of at least 3 months
•8. Neutrophils = 1.5 x 109/L and platelets = 100 x 109/L
•9. Bilirubin = 1.5 x UNL (Upper Normal Limit) and ASAT and/or ALAT = 3 x UNL. In case of liver metastases no UNL for ASAT and ALAT
•10. Creatinine clearance = 50 ml/min. Calculated with the Cockroft-Gault formular
•11. No neuropathy
•12. Planned treatment start within 8 days after inclusion
•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

•1. Patients who cannot complete treatment or evaluation
•2. Any condition or treatment which after the opinion of the investigator may expose the patients to a risc or influence the purpose of the study
•3. Known hypersensitivity towards any of the study drugs
•4. Other malignant disease within the last 5 days, except for non-melanoma skin cancer
•5. Other serious disease (e.g. cardiac disease, AMI within 1 year or infection)
•6. Pregnant women or nursing women
•7. Physical or mental conditions which may prevent absorption of oral treatment

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