This is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly
Department of Oncology, Aarhus Hospital
Aarhus, Aarhus, Denmark
Department of Oncology, Odense University Hospital
Odense, Odense, Denmark
Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)
Time frame: 4 months
Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer
Time frame: 4 months
Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death
Time frame: 18 months
Survival All events grade 1-5 according to NCI-CTCAE in fase I All Adverse events grade 1-5 according to NCI-CTCAEW in Fase II Correlation between effect of treatment and tumourmarkers Quality of life - EORTC QLQ Time to failure of Strategy
Time frame: 22 months
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