Phase II Trial to Assess FOLFIRI+Aflibercept Efficacy in Patients With Oxaliplatin-pretreated Metastatic Colorectal Cancer With or Without ACE Polymorphisms

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

December 31, 2018

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

FOLFIRI+aflibercept

"Aflibercept: 4 mg/kg administered intravenous infusion on day 1~FOLFIRI regimen immediately after aflibercept:~Irinotecan:180 mg/m2 intravenous infusion, folinic acid (dl racemic): 400 mg/m2 intravenous infusion, followed by 5-fluorouracil (5-FU): 400 mg/m2 intravenous bolus, followed by 5-FU: 2400 mg/m2 continuous intravenous infusion over 46 hours.~\* folinic acid: 400 mg/m² (racémic) or 200 mg/m² (L-form)"

Trial Locations (1)

28007

Spanish Cooperative Group for the Treatment of Digestive Tumors, Madrona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER