Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Status:
Completed
Trial end date:
2018-11-23
Target enrollment:
Participant gender:
Summary
For patients relapsing after platinum-based therapy, few data are available. The current use
of cetuximab associated with radiotherapy in localized disease and associated with
platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic
options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine
demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent
preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based
on a clinical review, show encouraging antitumour activity and an acceptable safety profile.
Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen
after platinum failure.
The present study has been designed as a multicenter, randomised phase III study which will
compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN
patients having failed platinum-based therapy.