At a glance
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Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab in Patients With Refractory, Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 2 clinical trial evaluating cetuximab, placebo, and 3 other interventions for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma and 36 related conditions. Completed, enrolled 55 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Given IV
Given orally
Given orally
Correlative studies
Ancillary studies