Optimal Control of Liver Metastases From Colorectal Cancer With Cetuximab and Hepatic Artery Infusion of Chemotherapy

PHASE2UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

March 31, 2012

Study Completion Date

December 31, 2015

Conditions
Metastatic Colorectal CancerLiver MetastasesHepatic Lesions
Interventions
DRUG

IV cetuximab

Cetuximab is administered every two weeks at the dose of 500 mg/m² over 2h30 (150 minutes).

DRUG

HAI chronomodulated chemotherapy

"Irinotecan (180 mg/m²) on day 2 as a 6 hour infusion, starting at 2:00, with a peak at 5:00~Oxaliplatin (85 mg/m²) in split daily doses for 3 days, starting on day 2. Daily sinusoidal infusion duration will last from 10:15 to 21:45, with peak delivery rate at 16:00.~5-Fluorouracil (2800 mg/m²) in split daily doses for 3 days, alternating with oxaliplatin infusions, starting on day 2. Daily sinusoidal infusions will last from 22:15 to 9:45 , with peak delivery at 4:00.~Treatments will be repeated every 2 weeks."

DRUG

HAI conventional chemotherapy

"Irinotecan (180 mg/m²) on day 1 as a one hour infusion, then~Oxaliplatin (85 mg/m²) on day 1 as a two hour infusion, then~5-Fluorouracil (2800 mg/m²) as a 48 h infusion starting on day 2, after completion of oxaliplatin delivery.~Treatments will be repeated every 2 weeks."

Trial Locations (14)

4000

Clinique Saint-Joseph, Liège

27000

Hospital Fernando Fonesca, Amadora

31059

CHU Toulouse, Toulouse

33000

CHU de Bordeaux, Hôpital Saint-André, Bordeaux

33170

Azienda Ospedaliera S.Maria Degli Angeli, Pordenone

59037

CHRU de Lille, Hôpital Claude Huriez, Lille

63011

Centre Jean Perrin, Clermont-Ferrand

66100

Università G. d'Annunzio, Chieti

75014

Hôpital Cochin, Paris

75015

Hôpital Européen Georges Pompidou, Paris

92100

Hôpital Ambroise Paré, Boulogne-Billancourt

94800

Chronotherapy Unit, Medical Oncology Department, Paul Brousse Hospital, Villejuif

Institut Gustave Roussy, Villejuif

00144

Istituto Regina Elena, Roma

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

collaborator

Merck Serono International SA

INDUSTRY

collaborator

Pfizer

INDUSTRY

collaborator

CRESGE

UNKNOWN

lead

Association pour la Recherche sur le Temps Biologique et la Chronothérapie

OTHER