Clinical trial NCT00382031: Zalutumumab in Patients With Non-curable Head and Neck Cancer
Official title: An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Squamous Cell Cancer
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

Detailed description: This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.

Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.

Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.

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 chemotherapy regimens other than platinum-based chemotherapy
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
timeFrame: From randomization until death
Secondary outcomes:
measure: Objective Tumor Response
timeFrame: From date of randomization until the date of death from any cause, assessed up to 41 months.
measure: Duration of Response
timeFrame: Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.
measure: Progression Free Survival (PFS)
timeFrame: From randomization until disease progression or death, assessed up to 41 months.
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Brussels
country: Belgium
facility: St-Luc University Hospital
city: Charleroi
country: Belgium
facility: CHNDRF
city: Gent
country: Belgium
facility: "University Hospital
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Ottignies
country: Belgium
facility: Cliniques Saint Pierre
city: Belo Horizonte
country: Brazil
facility: BioCancer
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
city: Goiânia
country: Brazil
facility: Centro Goiano de Oncologia
city: Goiânia
country: Brazil
facility: Hospital Araújo Jorge
city: Jaú
country: Brazil
facility: Fundação Amaral Carvalho
city: Porto Alegre
country: Brazil
facility: CliniOnco
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: Santo André
country: Brazil
facility: Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia
city: Santo André
country: Brazil
facility: Santo Andre Diag e Tratamentos
city: São Paulo - SP
country: Brazil
facility: UNIFESP
city: São Paulo
country: Brazil
facility: Centro de Oncologia - InRad HCFMUSP
city: São Paulo
country: Brazil
facility: Hospital Heliópolis
city: São Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Combate ao Câncer
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Vancouver, British Colombia
country: Canada
facility: BC Cancer Agency
city: Tallinn
country: Estonia
facility: North-Estonian Regional Hospital
city: Clichy
country: France
facility: Hôpital Beaujon- department of medical oncology
city: Lille Cedex
country: France
facility: Centre Oscar Lambrette
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris Cedex
country: France
facility: Hôpital Tenon - department of medical oncology
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Uzsoki Hospital Budapest
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Gyor
country: Hungary
facility: Petz Aladár
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg County Hospital
city: Szeged
country: Hungary
facility: University of Szeged
city: Szombathely
country: Hungary
facility: Markusovszky County Hospital
city: Tatabánya
country: Hungary
facility: Szent Borbála County Hospital Oncology Department
city: Zalaegerszeg-Pózca
country: Hungary
facility: Zala County Hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii
city: Gdansk
country: Poland
facility: Samodzielny Publiczny Szpital Kiniczny Nr1
city: Krakow
country: Poland
facility: Katedra i Onkologii Collegium
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Rydygiera
city: Lublin
country: Poland
facility: Centrum Onkologii
city: Olsztyn
country: Poland
facility: Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Zielona Góra
country: Poland
facility: Szpital Wojewódzki SP ZOZ
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Regional Oncology Dispensary
city: Izhevsk
country: Russian Federation
facility: Republican Clinical Oncology Dispensary
city: Kursk
country: Russian Federation
facility: Kursk Regional Oncology Dispencary
city: Kursk
country: Russian Federation
facility: Kursk Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: City Clinincal Oncology Dispensary #1
city: Moscow
country: Russian Federation
facility: Moscow Research Institute of Oncology
city: Moscow
country: Russian Federation
facility: NUZ Semashko Central Clinical Hospital No2 OAO
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n.a. Blokhin
city: Nizhiy Novgorod
country: Russian Federation
facility: GUZ NO Oncology Dispensary
city: Obninsk
country: Russian Federation
facility: Medical Radiological Research Center
city: Sochi
country: Russian Federation
facility: Sochi Oncology Center
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University
city: Stavropol
country: Russian Federation
facility: Stavropol Regional Clinical Oncology Dispensary
city: Tula
country: Russian Federation
facility: Tula Region Oncology Dispensary
city: Volgograd
country: Russian Federation
facility: GUZ Volgograd Region Clinical Oncology Dispensary No1
city: Voronezh
country: Russian Federation
facility: Voronezh Region Clinical Oncology Dispensary
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kamenica
country: Serbia
facility: Institute of Oncology Sremska Kamenica
city: Nis
country: Serbia
facility: Clinic of Maxillofacial Surgery Nis
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Lund University Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
state: Somerset
city: Guildford
country: United Kingdom
facility: Royal Surrey County
state: Surrey
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Centre
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle General Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
References:
citation: Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sorensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. doi: 10.1016/S1470-2045(11)70034-1. Epub 2011 Mar 4.