Clinical trial NCT00542308: Zalutumumab in Non-curable Patients With SCCHN
Official title: An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Squamous Cell Cancer
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.


Eligibility criteria: Inclusion Criteria:

1. Males and females age ≥ 18 years
2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion Criteria:

1. Three or more prior chemotherapy regimens
2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3. Past or current malignancy other than SCCHN, except for certain other cancer diseases

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization until death, assessed up to 21 months
Secondary outcomes:
measure: Objective Tumour Response
timeFrame: During treatment and two weeks after end of treatment, assessed up to 21 months.
measure: Duration of Response
timeFrame: During treatment and two weeks after end of treatment, assessed up to 21 months
measure: Progression Free Survival (PFS)
timeFrame: During treatment and two weeks after end of treatment, assessed up to 21 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Institute
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boise
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Ft. Wayne Medical Oncology/Hematology, Inc
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Medizin III
city: Wien
country: Austria
facility: AKH Wien
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur ICOS
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren de Valparaiso
city: Viña del Mar
country: Chile
facility: Instituto Oncologico
city: Bogota
country: Colombia
facility: Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Montería
country: Colombia
facility: Oncomedica S.A.
city: Pereira
country: Colombia
facility: Oncólogos del Occidente S.A.
city: Hradec Králové
country: Czechia
facility: Facultni Nemocnice Hradec Kralove
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Prague
country: Czechia
facility: Veseobecna Fakultni Nemocnice
city: Prague
country: Czechia
facility: Facultni Nemocnice Na Bulovce
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universität
city: Freiburg
country: Germany
facility: Uniklinik Freiburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Lübeck
country: Germany
facility: Medizinische Universitätsklinik Lübeck
city: Nordhausen
country: Germany
facility: Südharz-Krankenhaus Nordhausen gGmbH
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medial Center
city: Jerusalem
country: Israel
facility: Shaare-Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Milan
country: Italy
facility: Istituto Nazionale Tumori
city: Milan
country: Italy
facility: Istituto Europea di Oncologia
city: Sondrio
country: Italy
facility: Azienda Ospedaliera Valtellina e Valchiavenna
city: Arequipa
country: Peru
facility: Hospital Goyeneche
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo
city: Lambayeque
country: Peru
facility: Hospital Nacional Almanzor Aguinaga Asenjo
city: Lima
country: Peru
facility: Hospital Central FAP
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
city: Coimbra
country: Portugal
facility: IPO Coimbra
city: Lisboa
country: Portugal
facility: IPO Lisboa
city: Porto
country: Portugal
facility: IPO Porto
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Trnava
country: Slovakia
facility: FN Trnava
Study officials:
affiliation: Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
name: Steen Lisby, MD
role: STUDY_DIRECTOR
References:
citation: Saloura V, Cohen EE, Licitra L, Billan S, Dinis J, Lisby S, Gauler TC. An open-label single-arm, phase II trial of zalutumumab, a human monoclonal anti-EGFR antibody, in patients with platinum-refractory squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2014 Jun;73(6):1227-39. doi: 10.1007/s00280-014-2459-z. Epub 2014 Apr 9.