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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Methotrexate; Vinblastine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma

• Documented progressive disease after chemotherapy for locoregionally advanced or recurrent/metastatic SCCHN which included a platinum derivative

• Measurable or non measurable disease

• adequate haematological, hepatic and renal functions

• WHO performance status < 1

Exclusion Criteria:

• Nasopharyngeal carcinoma

• History of brain or leptomeningeal involvement

• Albumin level < 35 g/L

• Patients with weight loss ≥ 5% within the last 3 months

• Grade > 2 peripheral neuropathy at study entry

• "Third space" fluids (pleural effusion, ascites, massive edema)

• Prior treatment with vinca-alkaloids and methotrexate