drugset / Trial / NCT00939627

Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab

NCT00939627 ↗

Phase 2 Completed 55 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

Monoclonal antibodies, such as cetuximab, 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. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cetuximab is more effective when given alone or together with sorafenib tosylate in treating patients with head and neck cancer. This randomized phase II trial is studying cetuximab to see how well it works when given together with or without sorafenib tosylate in treating patients with refractory, recurrent, and/or metastatic head and neck cancer.

Timeline

Start
2009-07
Primary completion
2013-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody — Intravenous
Subject Sorafenib Small molecule — Oral