Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
There is no optimal treatment for patients with recurrent head and neck cancer after previous
radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10
months. Surgery is not always possible and often cannot remove every cancerous cell. On the
other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has
significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal
complications. Therefore, less toxic and more effective reirradiation regimens are urgently
needed. There are extensive data from animal studies and preliminary human studies showing
that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and
is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of
EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans
and appear to have less severe toxicity than conventional chemotherapeutic agents.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai Johnny Kao