Phase 3
Completed N=459
Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Source: ClinicalTrials.gov NCT02347332 ↗Enrolled (actual)
459
Serious AEs
41.4%
Results posted
Feb 2019
Primary outcomePrimary: Overall Survival in the ITT Population (Months) — 7.1; 6.8 Months — p=0.8329
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival in the ITT Population (Months) |
7.1; 6.8 | 0.8329 |
| SECONDARY Progression Free Survival |
2.8; 2.8 | 0.3576 |
| SECONDARY Objective Response Rate (ORR) |
17.8; 14.8 | 0.467 |
| SECONDARY Disease Control Rate |
50.9; 46.3 | 0.243 |
| SECONDARY Duration of Response |
4.2; 4.2 | 0.6289 |
Eligibility 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 2 peripheral neuropathy at study entry
- "Third space" fluids (pleural effusion, ascites, massive edema)
- Prior treatment with vinca-alkaloids and methotrexate
Data sourced from ClinicalTrials.gov (NCT02347332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.