NCT01718873

Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.

Detailed description

OBELICS is a two-arm phase 3 trial comparing in mCRC patients (1:1): concurrent administration of bevacizumab in combination with modified FOLFOX-6 regimen (mFOLFOX-6) or modified OXXEL regimen (mOXXEL), in which bevacizumab is administered the same day as oxaliplatin, (standard arm); and sequential administration of bevacizumab with the same chemotherapeutic regimens, in which bevacizumab is administered 4 days before oxaliplatin at each cycle (experimental arm) Oxaliplatin regimen (mFOLFOX/mOXXEL) is chosen according to local clinical practice at the beginning of the study.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-12-01
• Completion: 2019-12-01
• First posted: 2012-10-31
• Last updated: 2023-04-12
• Results posted: 2023-04-12

Locations

1 site across 1 country: Italy