FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2017

Primary Completion Date

January 21, 2021

Study Completion Date

January 21, 2021

Conditions
Colorectal NeoplasmsColorectal CarcinomaColorectal Cancer MetastaticNeoplasm Metastasis
Interventions
DRUG

Panitumumab

Panitumumab 6 mg/kg will be administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy

DRUG

Irinotecan

Irinotecan 150 mg/m2 will be administered as IV infusion over 90 min on day 1of first treatment cycle. If tolerance of this first dose is good, it will be scaled to a full dose of 180 mg/m2 starting from the second treatment cycle

DRUG

Folinic acid

Folinic acid 200-400 mg/m2 will be administered as IV infusion over 2 hours on day 1

DRUG

5-FU

5-FU will be administered IV 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2

Trial Locations (12)

25198

Hospital Universitario Arnau de Vilanova, Lleida

28046

Hospital Universitario la Paz, Madrid

28222

Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda

28933

Hospital Universitario Rey Juan Carlos, Móstoles

30008

Hospital General Universitario Morales Meseguer, Murcia

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

08908

ICO L´Hospitalet de Llobregat - Hospital Durán i Reynals, L'Hospitalet de Llobregat

08970

Hospital Sant Joan Despí-Moises Broggi, Sant Joan Despí

08036

Hospital Clínic, Barcelona

03600

Hospital General Universitario de Elda, Elda

07020

Hospital Universitario Son Espases, Palma

08208

Hospital Parc Taulí, Sabadell

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Pivotal S.L.

INDUSTRY

lead

Grupo Espanol Multidisciplinario del Cancer Digestivo

OTHER

NCT03142516 - FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status | Biotech Hunter | Biotech Hunter