drugset / Trial / NCT01079780

Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy

NCT01079780

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.

Timeline

Start
2011-01-18
Primary completion
2021-02-22
Completion
2021-08-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 150 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Irinotecan Small molecule 400 mg/m2 Intravenous
Subject Ramucirumab Monoclonal antibody 6 mg/kg Intravenous
Subject Ramucirumab Monoclonal antibody 8 mg/kg Intravenous

Indications