Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Condition: Recurrent or Metastatic Head and Neck Carcinoma
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This study was designed to compare the OS of VFL plus MTX versus MTX alone in patients with
      SCCHN who had failed platinum-based chemotherapy.

      The trial was designed in accordance with current standards used routinely in oncology phase
      III trials and used established methods of assessment. The RECIST (version 1.1) and NCI CTCAE
      (version 3.0) guidelines are internationally recognised methods for assessing efficacy and
      tolerance, respectively.

      The patient population was appropriate for this type of phase III study and included adult
      patients with recurrent and/or metastatic squamous cell carcinoma of the oral cavity,
      oropharynx, hypopharynx or larynx, who had received prior chemotherapy regimens with
      documented progression. This population of patients was considered appropriate to meet the
      study objectives.

      Recent preliminary phase I results of the VFL plus MTX combination in SCCHN, reported in a
      clinical review, showed encouraging antitumour activity and an acceptable safety profile A
      number of chemotherapy agents have been reported as having single-agent activity in SCCHN.
      However, reliable evidence of efficacy in the second-line setting is lacking, and there is
      currently no established standard of care. MTX used alone as the reference regimen at a dose
      of 40 mg/m2/week can be considered as the best available evidence-based option. Also, other
      trials using this comparator have demonstrated that it is generally accepted as a reasonable
      choice, and is often used in general practice.

      The efficacy and safety assessments employed in this study are standard measures routinely
      used in studies of this type
    

Intervention name(s): Vinflunine; Methotrexate
Intervention type(s): Drug; Drug
Other intervention name(s): JAVLOR; VFL; MTX
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vinflunin; Vinflunin + Methotrexate; Metastatic Squamous Cell Carcinoma of the Head and Neck