Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient

PHASE2CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

March 31, 2015

Conditions
Metastatic Colorectal Cancer
Interventions
OTHER

folfoxiri+cetuximab+surgery+cetuximab

"Induction FOLFOXIRI plus cetuximab will consist of:~* CETUXIMAB 500 mg/sqm IV over 1-h\* , day 1 followed by~* IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by~* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with~* l-LV 200 mg/sqm IV over 2-h, day 1 followed by~* 5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.~Surgical revaluation will be performed after the induction phase (8 cycles).~Patients deemed unsuitable for surgery will received maintenance treatment as follows:~•CETUXIMAB 500 mg/sqm IV over 60-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal."

OTHER

folfoxiri+cetuximab+surgery+bevacizumab

"Induction FOLFOXIRI plus cetuximab will consist of:~* CETUXIMAB 500 mg/sqm IV over 1-h\* , day 1 followed by~* IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by~* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with~* l-LV 200 mg/sqm IV over 2-h, day 1 followed by~* 5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.~Surgical revaluation will be performed after the induction phase (8 cycles).~Patients deemed unsuitable for surgery will received maintenance treatment as follows:~•BEVACIZUMAB 5 mg/kg IV over 30-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal."

Trial Locations (22)

10134

A.O. Universitaria S. Giovanni Battista-Molinette Di Torino - Torino (to) Oncologia Medica, Torino

12100

Azienza Ospedaliera S. Croce E Carle, Cuneo

15100

Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al) Oncologia Medica, Alessandria

16132

IRCCS ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO (IST) - GENOVA (GE) ONCOLOGIA MEDICA Oncologia Medica A, Genova

23100

Ospedale Civile Di Sondrio, Sondrio

25124

Istituto Ospedaliero Fondazione Poliambulanza Di Brescia - Brescia (Bs) Oncologia Medica, Brescia

25125

Pres.Ospedal.Spedali Civili Brescia - Brescia (Bs) Oncologia Medic, Brescia

33081

Irccs Centro Di Riferimento Oncologico (Cro) - Aviano (Pn), Aviano

33100

A.O. UNIVERSITARIA S. MARIA DELLA MISERICORDIA DI UDINE - UDINE (UD) ONCOLOGIA MEDICA U.O. Oncologia Medica, Udine

35128

Irccs Istituto Oncologico Veneto (Iov) - Padova (Pd) Oncologia Medica, Padua

40138

A.O.Universitaria Policlinico S.Orsola-Malpighi Di Bologna (Oncologia Medica), Bologna

42100

Ospedale Di S. Maria Nuova - Reggio Nell'Emilia (Re) Oncologia Medica, Reggio Emilia

50053

Ausl 12 Di Viareggio (Lu) - Lido Di Camaiore (Lu) Oncologia Medica, Lucca

56100

Polo Oncologico Area Vasta Nord Ovest, Pisa

AUSL 5 DI PISA - PISA (PI) ONCOLOGIA MEDICA oncologia medica Osp Lotti Pontedera, Pontedera

03100

AUSL DI FROSINONE - FROSINONE (FR) ONCOLOGIA MEDICA U.O. Oncologia Medica, Frosinone

06156

AZIENDA OSPEDALIERA DI PERUGIA - OSPEDALE S. MARIA DELLA MISERICORDIA - PERUGIA (PG) ONCOLOGIA MEDICA U.O. Oncologia Medica, Perugia

09121

Ospedale Armando Businco - Cagliari (Ca) Oncologia Medica, Cagliari

00128

Policlinico Universitario Campus Bio-Medico Di Roma - Roma (Rm) Oncologia Medica, Roma

00161

POLICLINICO UMBERTO I DI ROMA - ROMA (RM) ONCOLOGIA MEDICA oncologia Medica, Roma

00186

Ospedale Fatebenefratelli, Roma

00189

Ospedale San Pietro Fatebenefratelli - Roma (Rm) Oncologia Medica, Roma

All Listed Sponsors
lead

Gruppo Oncologico del Nord-Ovest

OTHER

NCT02295930 - Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient | Biotech Hunter | Biotech Hunter