A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

The present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.