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

NCT02347332 | Completed Phase 3 Results DMC

• 1 other identifier: L00070 IN 309 F0
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent or Metastatic Head and Neck Carcinoma

Keywords

Vinflunin; Vinflunin + Methotrexate; Metastatic Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Overall Survival in the ITT Population (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.

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

Secondary Outcomes (4)

• Progression Free Survival

  an expected average of 4 months

• Objective Response Rate (ORR)

  6 weeks

• Disease Control Rate

  30 months

• Duration of Response

  30 months

Study Arms (2)

Vinflunine plus methotrexate

EXPERIMENTAL

vinflunine IV 280 mg/m² Day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks

Drug: Vinflunine

Methotrexate

ACTIVE COMPARATOR

methotrexate IV 40 mg/m² Day 1, 8 and 15 every 3 weeks

Drug: Methotrexate

Interventions

Vinflunine DRUG

Also known as: JAVLOR, VFL

Vinflunine plus methotrexate

Methotrexate DRUG

Also known as: MTX

Methotrexate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (1)

Institut de Recherche Pierre Fabre

Toulouse, France

Location

MeSH Terms

Conditions

Recurrence; Squamous Cell Carcinoma of Head and Neck

Interventions

vinflunine; Methotrexate

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Sponsor ended recrutement and decided to limit analysis of efficacy.

Results Point of Contact

• Title: Zahida Issiakhem, Clinical Development Physician
• Organization: Institut de Recherche Pierre Fabre, Toulouse France

zahida.issiakhem@pierre-fabre.com

+33 5 34 50 61 71

Study Officials

• Zahida Issiakhem, MD

  Institut de Recherche Pierre Fabre

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: January 27, 2015
• Study Start: April 25, 2014
• Primary Completion: October 20, 2017
• Study Completion: November 23, 2018
• Last Updated: March 5, 2019
• Results First Posted: February 4, 2019

Record last verified: 2019-02

Locations

FR (1)