CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

219

Participants

Timeline

Start Date

July 15, 2021

Primary Completion Date

August 15, 2026

Study Completion Date

August 15, 2026

Conditions
Metastatic Colorectal Adenocarcinoma
Interventions
DRUG

Cetuximab

"I LINE:~\- FOLFIRI + cetuximab~FOLFIRI: 200 mg L-folinic acid with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.~Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter~II LINE:~\- FOLFOX + cetuximab~FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.~Cetuximab: as I line~THIRD LINE:~\- Irinotecan + cetuximab~Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line"

DRUG

FOLFIRI

"I LINE:~\- FOLFIRI + cetuximab~FOLFIRI: 200 mg L-folinic acid given concurrently with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.~Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter"

DRUG

FOLFOX regimen

"II LINE:~\- FOLFOX + cetuximab~FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.~Cetuximab: as I line"

DRUG

Irinotecan

"III LINE:~\- Irinotecan + cetuximab~Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line"

Trial Locations (25)

Unknown

A.O.U. Ospedali Riuniti, Ancona

Ente Ecclesiastico Ospedale Generale Regionale 'F. Miulli', Acquaviva delle Fonti

IRCCS Istituto Tumori 'Giovanni Paolo II', Bari

Ospedale IRCCS 'Saverio de Bellis', Castellana Grotte

Ospedale Sacro Cuore di Gesù - FATEBENEFRATELLI, Benevento

P.O. Antonio Perrino, Brindisi

A.O.U. Cagliari - Presidio Policlinico D. Casula, Monserrato

A.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima, Catania

A.O.U. Mater Domini, Catanzaro

Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

P.O. 'Vito Fazzi', Lecce

A.O. 'Pia Fondazione Cardinale G. Panico', Tricase

Istituto Europeo di Oncologia, Milan

A.O.U. Policlinico 'P. Giaccone', Palermo

Istituto Oncologico Veneto IRCCS, Padua

A.O.U. Pisana, Pisa

A.O. San Carlo, Potenza

A.U.S.L. - IRCCS di Reggio Emilia - P.O. Arcispedale S.Maria Nuova, Reggio Emilia

A.S.P. Ragusa - Ospedale Maria Paternò Arezzo, Ragusa

A.O. San Camillo-Forlanini, Roma

Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS, Roma

Ospedale San Giuseppe Moscati, Statte

A.O. Ordine Mauriziano, Torino

"A.O.U. dell'Università degli studi della Campania Luigi Vanvitelli", Napoli

Istituto Nazionale Tumori 'Fondazione G. Pascale', Napoli

All Listed Sponsors
lead

University of Campania Luigi Vanvitelli

OTHER