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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Capecitabine; Gemcitabine

Criteria

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.