Epirubicin as 2nd line treatment to patients with TOP2A gene amplified and oxaliplatin refractory metastatic colerectal cancer - Epirubicin

Odense University Hospital0 个研究点目标入组 25 人开始时间: 2013年7月22日最近更新: 2013年9月9日

试验速览

暂无简介。

•Histologically verified CRC with non-resectable mCRC
•Oxaliplatin resistant disease i.e. progression during or after oxaliplatin-based therapy
•Available FFPE tumor tissue blocks and TOP2A/CEN-17 ratio = 1.5 in their malignant tumor cells in the primary tumor biopsy or in a biopsy from a metastatic lesion
•Measurable or non-measurable disease
•Age = 18 years
•Performance status (WHO) of 0-2 and a life expectancy of at least 3 months
•Adequate haematological function defined as ANC = 1.5 x 109/l and platelets = 100 x 109/l
•Adequate liver function defined as bilirubin = 1,5 x UNL (upper normal limit)
•Written informed consent
•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 13
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•Previous or synchronous malignancy, with the exception of adequately treated basal cell skin cancer or cervical cancer in situ
•Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives
•Pregnant or lactating women (in fertile women this is ensured according to guidelines of Danish Health and Medicines Authority)
•Known hypersensitivity to epirubicin
•Known heart disease
•Prior treatment of mCRC with a topoisomerase inhibitor e.g. irinotecan

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