drugset / Trial / NCT00881114

Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer

NCT00881114 ↗

Phase 2 Withdrawn Georgetown University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a study for patients with head and neck cancer who will be receiving chemotherapy and radiation therapy for their disease. The purpose of this study is to see if the investigators can use genetic differences between patients to select the right drug to use with radiation therapy. This type of genetic testing is called pharmacogenetics. Currently there are two drugs used to treat head and neck cancer that have provided a benefit when given with radiation compared to radiation alone in previous studies. These two drugs are cisplatin and cetuximab (Erbitux). In this trial, the investigators will test whether genetic differences between patients can be used to pick which drug they should receive. A recent study that looked back to see how well patients with head and neck cancer responded to treatment with cisplatin showed that genetic differences in a few genes were associated with who did and who did not survive their cancer. The investigators are taking that finding and using it to test patients for these genetic differences to determine whether they should receive cisplatin or cetuximab. In other words, the investigators are trying to take what is essentially a flip of the coin choice between these two drugs, and instead use individual patient's genetic differences to make-and hopefully improve- this choice.

Timeline

Start
2009-04
Primary completion
2009-06
Completion
2013-06

Outcome

Outcome not reported

Stopped: “Investigator decided it was not feasible to conduct this study”

Drugs

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