A Prospective Phase II Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous
cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as
primary therapy with curative intent will be enrolled. Patients will be genotyped for
variations at four SNP loci in 3 genes involved in DNA nucleotide excision repair (ERCC1,
ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin, while patients with
2 or fewer variants will receive cetuximab.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
36months
No
John Deeken, MD
Principal Investigator
Georgetown University
United States: Institutional Review Board
PGx-SELECT
NCT00881114
April 2009
June 2013
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