In this randomised , multicentre , open-label , phase 2 trial , patients with metastatic pancreatic adenocarcinoma , World Health Organisation ( WHO ) performance status 0-1 , and bilirubin levels < 1.5 upper limit of normal values ( ULN ) were randomised 1:1 to receive as first-line treatment either FOLFIRI .3 ( irinotecan , leucovorin and fluorouracil ) alternating with fixed-dose rate gemcitabine as 2-month periods ( FIRGEM , arm A ) , or fixed-dose rate gemcitabine alone ( arm B ) .