drugset / Trial / NCT01564810

Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer

NCT01564810 ↗

Phase 4 Unknown 150 enrolled Xu jianmin
RandomizedParallel-groupOpen-labelTreatment

Summary

In this study, the investigators assessed the effect of Cetuximab in combination with chemotherapy in the treatment of unresectable metastatic colorectal cancer.

Timeline

Start
2006-09
Primary completion
2012-06
Completion
2015-09

Outcome

Met primary endpoint

paper R0 resection rates for liver metastases were 25.7% (18 of 70 patients) in arm A and 7.4% (five of 68 patients) in arm B PMID 23569301 ↗

paper which were significantly different (P < .01). PMID 23569301 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 200 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 600 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous