NCT02316496

Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study

A Phase II Study of Cetuximab Rechallenge in Combination With Irinotecan in Advanced Metastatic Colorectal Cancer Without KRAS or NRAS or BRAF Mutation (All Wild Type) for Patients Pretreated With FOLFIRI and Cetuximab in First Line With Stopping Cetuximab for Progressive Disease After a Previous Response (Partial Response or Complete Response) and After Treatment With a Fluoropyrimidine, Oxaliplatin Plus Bevacizumab Regimen

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer. Secondaries objectives will be assessed progression-free survival, overall survival, toxicity, quality of life.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	cetuximab	cetuximab 500mg/m²/ IV infusion, (q2w)
DRUG	Irinotecan	Irinotecan 180mg/m², in 500ml NaCl 0.9% solution, 90 min IV infusion (q2w)

Timeline

• Start date: 2015-09-23
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2014-12-15
• Last updated: 2017-08-01

Locations

20 sites across 1 country: France