Clinical trial · Interventional
Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Phase III Study of IV Vinflunine in Combination With Methotrexate Versus Methotrexate Alone in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Head and Neck Carcinoma | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
| Vinflunine | Drug | Vinflunine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vinflunine plus methotrexate
- description
- vinflunine IV 280 mg/m² Day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks
- interventionNames
- Drug: Vinflunine
- type
- ACTIVE_COMPARATOR
- label
- Methotrexate
- description
- methotrexate IV 40 mg/m² Day 1, 8 and 15 every 3 weeks
- interventionNames
- Drug: Methotrexate
Primary outcomes (1)
- measure
- Overall Survival in the ITT Population (Months)
- timeFrame
- Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available