Phase II Study of gemcitabin and capecitabine in Chemotherapy Refractory Metastatic Colorectal Cancer - GemCap

Vejle Hospital0 个研究点目标入组 33 人开始时间: 2011年9月7日最近更新: 2021年4月19日

适应症

试验速览

暂无简介。

•Histologically verified colorectal adenocarcinomas
•Age > 18 years
•Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents.
•Measurable disease according to RECIST 1.1
•ECOG performance status 0, 1 or 2
•Adequate renal, hepatic and haematological function
•Consent to blood samples and available paraffin embedded tumour material for translational research studies
•Fertile males and females (<2 years after last period for women) must use effective birth control.
•Signed 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Clinically significant concurrent disease.
•Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
•Other experimental therapy within 30 days of treatment initiation.
•Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception.
•Clinical or radiological evidence of CNS metastasis.
•Planned radiation therapy against target-lesions.
•Known allergy to 5FU/capecitabine or gemcitabin

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