The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with unresectable liver metastases from colorectal cancer. Secondary objectives are safety and tolerability of hepatic chemoembolization and the question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and emesis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Starting dose of 400mg/m2, followed by weekly 250mg/m2
Irinotecan 180 mg/m² to be administered every two weeks
A minimum of two treatments per lobe (four bi-weekly sessions in the event of bilobar disease) at week 0 and 4 with up to 4ml (100-300µm DC Bead loaded with up to 200mg irinotecan) will be scheduled (i.e. for bilobar disease right lobe: week 0, left lobe: week 2, right lobe: week 4 and left lobe: week 6: following toxicity and extending interval if toxicity seen).
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Dresden, Germany
Zentralklinik Bad Berka GmbH, Abteilung für Interventionelle Radiologie
Bad Berka, Germany
Kliniken Essen-Mitte, Klinik für Innere Medizin IV
Essen, Germany
Klinikum Esslingen, Klinik für Onkologie, Gastroenterologie und Allgemeine Innere Medizin
Esslingen am Neckar, Germany
Krankenhaus Nordwest
Frankfurt/M., Germany
Universitätsklinikum der Johann Wolfgang Goethe Universität Frankfurt
Frankfurt/M., Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
SLK-Kliniken Heilbronn
Heilbronn, Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany
...and 3 more locations
Progression free survival rate
Time frame: 6 months after first administration of study medication
Tumour Response (according to RECIST v1.1)
extent of treated lesions
Time frame: every three months up to progression of disease, maximum 12 months from the date of patient enrolment
Time to progression
Time frame: every three months, until death of patient, maximum 12 months from the date of patient enrolment
Number of adverse events in study patients
Time frame: whole study, every two weeks until 28 days from the date of last administration of study medication
Local tumour response
extent of necrosis in the treated lesions
Time frame: every three months up to progression of disease, maximum 12 months from the date of patient enrolment
Overall survival
Time frame: every three months, until death of patient, maximum 12 months from the date of last patient enrolment
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