A randomized phase II trial of irinotecan drug-eluting beads administered by hepatic chemoembolization with intravenous cetuximab (DEBIRITUX) versus systemic treatment with intravenous cetuximab and irinotecan in patients with refractory metastatic colorectal cancer and k-ras wild-type tumours - DEBIRITUX

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients with unresectable liver metastases of colorectal cancer who previously failed pretreatment with 5FU/oxaliplatin and/or 5FU/irinotecan (2nd- or 3rd-line).
Sponsor: Martin Luther Universität Halle-Wittenberg
Enrollment: 80
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

November 4, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Patients with confirmed diagnosis of stage IV (UICC) colorectal cancer with unresectable liver metastases (primary tumour may be present) and k\-ras wild\-type tumours
•2\) Patients had been treated and shown to be refractory to 5\-FU (Capecitabine allowed)/oxaliplatin and/or 5\-FU/irinotecan. Prior therapy with VEGF\-inhibitors (e.g bevacizumab) is allowed
•3\) Patients with at least one measurable liver metastasis, with size \> 1cm (RECIST criteria)
•4\) Patients with liver only or liver dominant disease (defined as \= 50 % tumour burden confined to the liver)
•5\) Patients with a portal vein not interfering with transarterial chemoembolization (e.g. no thrombosis) as judged by the investigator
•6\) ECOG Performance status \= 2
•7\) Life expectancy \> 3 months
•8\) Age \= 18 years.
•9\) At least 4 weeks since last administration of last chemotherapy and/or radiotherapy (bone metastases may be allowed)
•10\) Patients who received VEGF\-inhibition (e.g. with bevacizumab) in prior therapy are eligible if stopped since 4\-6 weeks before randomization

•1\) Presence of CNS metastases
•2\) Contradindications to irinotecan therapy (Chronic inflammatory bowel disease and/or bowel obstruction, history of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate)
•3\) Active bacterial, viral or fungal infection within 72 hours of study entry
•4\) Women who are pregnant or breast feeding
•5\) Allergy to contrast media
•6\) Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
•7\) Any contraindication for hepatic embolisation procedures:
•Large shunt as determined by the investigator (pretesting with lung perfusion scan not required)
•Severe atheromatosis
•Hepatofugal blood flow