Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

419

Participants

Timeline

Start Date

October 15, 2018

Primary Completion Date

June 28, 2025

Study Completion Date

June 28, 2025

Conditions
Colorectal Cancer
Interventions
DRUG

FOLFOX regimen

oxaliplatin 85 mg/m2 administered by IV infusion over 120 minutes on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46- 48 hours on Days 1 and 2

DRUG

Panitumumab

6 mg/kg administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 14-day cycle

DRUG

Bevacizumab

5 mg/kg administered by IV infusion over 60 minutes on Day 1 of each 14-day cycle

DRUG

FOLFIRI regimen

irinotecan 180 mg/m2 administered as a 90 minutes IV infusion on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46-48 hours on Days 1 and 2

Trial Locations (1)

28007

Spanish Cooperative Group for the Treatment of Digestive Tumors, Madrid

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

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

OTHER