Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN
Status:
Completed
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
This is a non-randomized, open-label phase II trial of 38 patients with recurrent or
metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance
status of 0-1 with good organ function and will be treated with six weekly cycles of
carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating
physician at their discretion may continue to treat with weekly cetuximab as maintenance
until disease progression. The study is designed to evaluate whether this regimen improves
median overall survival (OS) as compared to an historical control population treated with a
platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for
recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource
intensive. Our study regimen has been used extensively for induction therapy and off-protocol
in palliative care, but treatment outcomes have yet to be defined by a clinical trial.