Status:
COMPLETED
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
Lead Sponsor:
Vejle Hospital
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01472770
Start Date
October 1 2011
End Date
May 1 2014
Last Update
December 4 2014
Active Locations (1)
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1
Department of Oncology, Vejle Hospital
Vejle, Denmark, 7100