Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Information source: Pierre Fabre Medicament
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent or Metastatic Head and Neck Carcinoma
Intervention: vinflunine (Drug); Methotrexate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Pierre Fabre Medicament
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: overall survival
Secondary outcome: Progression Free Survivaloverall response and disease control rate Number of participants with adverse events Quality of Life
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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 < 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
Locations and Contacts
Institut de Recherche Pierre fabre, Boulogne Billancourt, Ile de France 92654, France; Recruiting Vitor Angelico, MD, Phone: 0033 1 49 10 80 09, Email: vitor.angelico@pierre-fabre.com Philippe Massiot, Phone: 0033 1 49 10 83 31, Email: philippe.massiot@pierre-fabre.com
Vitor Angelico, Boulogne-Billancourt, Ile de France 92654, France; Recruiting Vitor Angelico, MD, Phone: 033 1 49108009, Email: vitor.angelico@pierre-fabre.com
Vitor Angelico, Boulogne, Ile de France 92654, France; Recruiting Vitor Angelico, MD, Phone: 0033 1 40 10 80 09, Email: vitor.angelico@pierre-fabre.com Philippe Massiot, Phone: 0033 1 49 10 83 31, Email: philippe.massiot@pierre-fabre.com
Vitor Angelico, Boulogne, Ile de France 92654, France; Recruiting Vitor Angelico, MD, Phone: 0033 1 49 10 80 09, Email: vitor.angelico@pierre-fabre.com Philippe Massiot, Phone: 0033 1 49 10 83 31, Email: philippe.massiot@pierre-fabre.com
Additional Information
Starting date: April 2014
Last updated: January 21, 2015
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