drugset / Trial / NCT01321957

Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer

NCT01321957 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the efficacy of Irinotecan in combination with FOLFOX+Bevacizumab versus FOLFOX+Bevacizumab alone in the first-line treatment of patients with metastatic colorectal cancer.

Timeline

Start
2011-05
Primary completion
2016-09
Completion
2018-08-15

Outcome

Met primary endpoint

paper The addition of irinotecan to FOLFOX/bevacizumab increased PFSR@9 from 56 to 67%, meeting the primary endpoint. PMID 37996507 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 165 mg/m2 Intravenous
Comparator Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Comparator I-LV Unknown 200 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous
Comparator fluorouracil Small molecule 3200 mg/m2 Intravenous

Indications