Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 30, 2014

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2018

Conditions
Colorectal CancerMetastatic Colorectal Cancer
Interventions
DRUG

5-FU

400 mg/m2 IV bolus day 1 followed by 2400 mg/m2 continuous IV infusion over 46 hours (days 1 and 2) every 14 days until disease progression

DRUG

LV

400 mg/m2 IV day 1 every 14 days until disease progression

DRUG

ziv-aflibercept

4 mg/kg IV day 1 every 14 days for 6 cycles (induction regimen); 4 mg/kg IV day 1 every 14 days until disease progression (continuation regimen)

DRUG

mFOLFOX6

5-FU 400 mg/m2 IV bolus plus leucovorin 400 mg/m2 IV plus oxaliplatin 85 mg/m2 IV on day 1 followed by 5-FU 2400 mg/m2 continuous IV infusion over 46 hours (days 1 and 2) every 14 days

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

NSABP Foundation Inc

NETWORK