673
Participants
Start Date
March 31, 2015
Primary Completion Date
January 30, 2025
Study Completion Date
January 30, 2025
Irinotecan
Irinotecan 180 mg/m² iv, 30 - 90 min., day 1, q d15
Folinic Acid
Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1, q d15
5-FU
5-FU 400 mg/m² bolus day 1, q d15
5-FU
5-FU 2400 mg/m² iv over 46 h day 1-2, q d15
Cetuximab
cetuximab initially 400 mg/m² as a 120 min. infusion (≤ 5mg/min); subsequently 250 mg/m² iv respectively as a 60 min. infusion (≤ 10mg/min) day 1 + 8
Bevacizumab
Bevacizumab 7.5 mg/kg BW iv over 30 to 90 minutes: day 1
Capecitabine
Capecitabine 1250 mg/m2 2 x day p.o. day 1-14, q d15
regorafenib
160 mg per day (day 1-21) (repeated on day 28)
Irinotecan 125mg
Irinotecan 125 mg/m² iv, 60 - 90 min. weekly (D1, D8, D15, D22)
Cetuximab wkly
Cetuximab initially 400 mg/m² as a 120 min. infusion (≤ 5mg/min); subsequently 250 mg/m² iv respectively as a 60 min. infusion (≤ 10mg/min) weekly (D1, D8, D15, D22, D29, D36)
Klinikum der Universitaet Muenchen - Campus Grosshadern, Munich
Ludwig-Maximilians - University of Munich
OTHER