A Pilot Prospective 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
germline variations at four SNP loci in three genes involved in DNA nucleotide excision
repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin (Arm
A). Patients with 2 or fewer variants will receive cetuximab (Arm B).
The hypothesis of the study is that prospectively testing patients for variations in DNA
repair enzymes to determine whether to use cisplatin or cetuximab in locally advanced head
and neck squamous cell cancer is feasible.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility is defined as follows: Patients' genetic test results are returned within 72 hours for at least 16 patients Genetic testing delays treatment initiation for less than 2 patients Fewer than 2 patients withdraw from study after enrollment
John F Deeken, MD
United States: Institutional Review Board
|Georgetown Lombardi Comprhensive Cancer Center||Washington, District of Columbia 20007|