Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2019

Conditions
Colorectal Cancer
Interventions
DRUG

Bevacizumab

5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.

DRUG

Oxaliplatin

85mg/m2 IV every 2 weeks for up to 24 weeks

DRUG

levo-folinic acid

200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks

DRUG

5-fluorouracil

400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)

DRUG

Capecitabine

1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)

Trial Locations (1)

Unknown

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

All Listed Sponsors
lead

National Cancer Institute, Naples

OTHER

NCT01718873 - Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter