Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab

PHASE3CompletedINTERVENTIONAL
Enrollment

673

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

January 30, 2025

Study Completion Date

January 30, 2025

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Irinotecan

Irinotecan 180 mg/m² iv, 30 - 90 min., day 1, q d15

DRUG

Folinic Acid

Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1, q d15

DRUG

5-FU

5-FU 400 mg/m² bolus day 1, q d15

DRUG

5-FU

5-FU 2400 mg/m² iv over 46 h day 1-2, q d15

DRUG

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

DRUG

Bevacizumab

Bevacizumab 7.5 mg/kg BW iv over 30 to 90 minutes: day 1

DRUG

Capecitabine

Capecitabine 1250 mg/m2 2 x day p.o. day 1-14, q d15

DRUG

regorafenib

160 mg per day (day 1-21) (repeated on day 28)

DRUG

Irinotecan 125mg

Irinotecan 125 mg/m² iv, 60 - 90 min. weekly (D1, D8, D15, D22)

DRUG

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)

Trial Locations (1)

81377

Klinikum der Universitaet Muenchen - Campus Grosshadern, Munich

All Listed Sponsors
lead

Ludwig-Maximilians - University of Munich

OTHER

NCT02934529 - Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab | Biotech Hunter | Biotech Hunter