drugset / Trial / NCT01790516

Use of Pharmacogenetics to Select Erbitux or Cisplatin to Treat Head and Neck Cancer

NCT01790516

Terminated 2 enrolled Georgetown University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery. The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with radiation therapy. In this study the investigators will test whether genetic differences between patients can be used to pick which of these two drugs a patient should receive. All patients will have a blood sample drawn that will be tested for genetic differences. If patients have genetic differences that correlate with a better outcome from cisplatin they will receive cisplatin with radiation. If patients have genetic differences that do not correlate with a better outcome from cisplatin they will receive cetuximab with their radiation therapy.

Timeline

Start
2012-05
Primary completion
2013-03
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2
Subject Cisplatin Other / unclassified 100 mg/m2