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
About half of patients with newly diagnosed colorectal cancer will develop metastatic
disease and, however, in spite of the significant progress in the therapeutical strategies
for metastatic disease, virtually all patients will eventually succumb to their illness.
Based on prior clinical data there is a good rationale for the expectation that the
combination of systemic chemotherapy and arterial chemoembolization with drug eluting beads
may be effective in the setting of patients with unresectable or chemorefractory liver
metastases. The aim of this study is therefore to assess whether the combination of
Irinotecan eluting beads and intravenous cetuximab is safe and effective in the treatment of
patients with unresectable liver metastases from refractory colorectal cancer and will
result in a prolongation of disease control when compared to standard systemic treatment
with intravenous irinotecan and intravenous cetuximab. In this patient group, intravenous
irinotecan plus intravenous cetuximab may represent the "standard of care", with a
previously described activity. The patient group is defined in terms of pretreatment, and
the scientific question is whether the way of irinotecan administration by eluting beads in
feasible and somehow beneficial.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival rate
6 months after first administration of study medication
No
Dirk Arnold, MD
Principal Investigator
Universitätsklinikum Eppendorf, Universitäres Cancer Center
Germany: Federal Institute for Drugs and Medical Devices
EudraCT: 2009-014728-44
NCT01060423
February 2010
September 2013
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