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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 Survival

overall 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

Page last updated: August 23, 2015

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