drugset / Trial / NCT02292758

Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

NCT02292758 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized phase II trial studies how well irinotecan and cetuximab with or without bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to other places in the body (locally advanced/metastatic) and cannot be removed by surgery. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cetuximab and bevacizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in treating patients with colorectal cancer.

Timeline

Start
2014-12-12
Primary completion
2019-03-20
Completion
2019-09-27

Outcome

Missed primary endpoint

paper There was no significant difference in the primary endpoint of PFS between CBI and CI. PMID 35380713 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous