Aflibercept and Chemotherapy as First Line Treatment for Metastatic Colorectal Cancer Assessable With DCE-US (PULSAR).

PHASE2TerminatedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

November 2, 2018

Study Completion Date

October 22, 2019

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Aflibercept-FOLFIRI

"Aflibercept : 4 mg/kg, IV over 1 h on Day 1~FOLFIRI :~* Irinotecan 180 mg/m² IV infusion in 500 mL D5W (5% Dextrose in Water solution) over 90 minutes and dl leucovorin\* 400 mg/m² IV infusion over 2 hours, at the same time, in bags using a Y-line, followed by :~* 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by :~* 5-FU 2400 mg/m² continuous IV infusion in 500 mL over 46-hours.~ * \*400 mg/m² of leucovorin expressed in dl racemic. When the l-isomer form is used the dose should be divided by 2, i.e. 200 mg/m²"

Trial Locations (8)

13273

Institut Paoli Calmettes, Marseille

21079

Centre Georges François Leclerc, Dijon

33076

Institut Bergonié, Bordeaux

59020

Centre Oscar Lambret, Lille

59037

CHRU, Lille

94275

Kremlin Bicetre, Le Kremlin-Bicêtre

94804

Hôpital Universitaire Paul Brousse, Villejuif

94805

Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Centre Oscar Lambret

OTHER