A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
- Histologically verified colorectal adenocarcinomas
- Age > 18 years
- Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant
- 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
- Signed Informed consent
- 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 gemcitabine.