A Study of Bevacizumab and Modified FOLFOX-6 (mFOLFOX-6) in Participants With Metastatic Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

August 12, 2011

Primary Completion Date

May 28, 2014

Study Completion Date

May 18, 2016

Conditions
Colorectal Cancer
Interventions
DRUG

5-Fluorouracil (5-FU)

Participants will receive 5-FU 400 mg per meter-squared (mg/m\^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m\^2, continuous infusion over 46 hours up to 12 cycles.

DRUG

Bevacizumab

Participants will receive 5 mg/kg bevacizumab IV dose on Day 1 of each 2 weeks' cycle up to Cycle 5 and thereafter cycles 7 to 12; followed by maintenance therapy of 5 mg/kg IV every 2 weeks up to 52 weeks (26 cycles).

DRUG

Levofolinic acid

Participants will receive levofolinic acid 200 mg/m\^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle up to 12 cycles.

DRUG

Oxaliplatin

Participants will receive oxaliplatin 85 mg/m\^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle up to 12 cycles.

Trial Locations (11)

20132

Irccs Ospedale San Raffaele;Oncologia Medica, Milan

20141

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milan

21013

Azienda Ospedaliera Sant' Antonio Abate; Divisione di Oncologia, Gallarate

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

40138

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna

41100

A.O. Universitaria Policlinico Di Modena; Ematologia, Modena

60121

Ospedali Riuniti Di Ancona; Oncology, Ancona

80131

IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A, Napoli

95122

Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica, Catania

95126

Centro Catanese Di Oncologia; Oncologia Medica, Catania

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01383707 - A Study of Bevacizumab and Modified FOLFOX-6 (mFOLFOX-6) in Participants With Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter