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NCT Number: NCT02347332

Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer

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.

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Key information

Conditions

Recurrent or Metastatic Head and Neck Carcinoma Carcinoma Carcinoma, Squamous Cell Disease Attributes Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Squamous Cell Carcinoma of Head and Neck

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut de Recherche Pierre Fabre

Toulouse, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vinflunine

Drug

Other names: JAVLOR, VFL

methotrexate

Drug

Other names: MTX

Primary outcomes

  1. Overall Survival in the ITT Population (Months)

    Time frame: Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months

    Time from randomization to the date of death or last follow-up. The survival duration of patients still alive, was censored at the date of last contact or last follow-up.

Secondary outcomes

  1. Progression Free Survival

    Time frame: an expected average of 4 months

    Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)

  2. Objective Response Rate (ORR)

    Time frame: 6 weeks

    The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.

  3. Disease Control Rate

    Time frame: 30 months

    Percentage of best overall responses CR, PR and SD in the analysed population

  4. Duration of Response

    Time frame: 30 months

    Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jan 27, 2015
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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