Zalutumumab in Patients With Non-curable Head and Neck Cancer

Phase 3

Completed

Conditions: Head and Neck Cancer
Squamous Cell Cancer

Interventions: Drug: Zalutumumab
Other: Control

Registration Number: NCT00382031

Lead Sponsor: Genmab

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 286

Inclusion Criteria

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

Exclusion Criteria

Three or more chemotherapy regimens other than platinum-based chemotherapy
Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
Past or current malignancy other than SCCHN, except for certain other cancer diseases

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zalutumumab	Zalutumumab	Zalutumumab in combination with Best Supportive Care
zalutumumab	Control	Zalutumumab in combination with Best Supportive Care
Control	Control	Best Supportive Care

Primary Outcome Measures

Name	Time	Method
Overall Survival	From randomization until death	A patient's overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.

Secondary Outcome Measures

Name	Time	Method
Objective Tumor Response	From date of randomization until the date of death from any cause, assessed up to 41 months.	Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR
Duration of Response	Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.	Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented.
Progression Free Survival (PFS)	From randomization until disease progression or death, assessed up to 41 months.	PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient.

Trial Locations

Locations (82): Cliniques Saint Pierre
🇧🇪
Ottignies, Belgium
Cross Cancer Institute
🇨🇦
Edmonton, Alberta, Canada
IBCC - Instituto Brasileiro de Combate ao Câncer
🇧🇷
São Paulo, Brazil
Kursk Regional Oncology Dispensary
🇷🇺
Kursk, Russian Federation
Kursk Regional Oncology Dispencary
🇷🇺
Kursk, Russian Federation
Musgrove Park Hospital
🇬🇧
Taunton, Somerset, United Kingdom
University Hospital Antwerp
🇧🇪
Antwerp, Belgium
University Hospital Leuven
🇧🇪
Leuven, Belgium
Lund University Hospital
🇸🇪
Lund, Sweden
NUZ Semashko Central Clinical Hospital No2 OAO
🇷🇺
Moscow, Russian Federation
Medical Radiological Research Center
🇷🇺
Obninsk, Russian Federation
GUZ NO Oncology Dispensary
🇷🇺
Nizhiy Novgorod, Russian Federation
The Beatson West of Scotland Centre
🇬🇧
Glasgow, United Kingdom
Weston Park Hospital
🇬🇧
Sheffield, United Kingdom
St. Petersburg State Medical University
🇷🇺
St. Petersburg, Russian Federation
Clinic of Maxillofacial Surgery Nis
🇷🇸
Nis, Serbia
GUZ Volgograd Region Clinical Oncology Dispensary No1
🇷🇺
Volgograd, Russian Federation
New Cross Hospital
🇬🇧
Wolverhampton, United Kingdom
Stavropol Regional Clinical Oncology Dispensary
🇷🇺
Stavropol, Russian Federation
Russian Oncology Research Center n.a. Blokhin
🇷🇺
Moscow, Russian Federation
Christie Hospital
🇬🇧
Manchester, United Kingdom
City Clinincal Oncology Dispensary #1
🇷🇺
Moscow, Russian Federation
Regional Oncology Dispensary
🇷🇺
Chelyabinsk, Russian Federation
Republican Clinical Oncology Dispensary
🇷🇺
Izhevsk, Russian Federation
Szpital Wojewódzki SP ZOZ
🇵🇱
Zielona Góra, Poland
Sochi Oncology Center
🇷🇺
Sochi, Russian Federation
Moscow Research Institute of Oncology
🇷🇺
Moscow, Russian Federation
Military Medical Academy
🇷🇸
Belgrade, Serbia
Institute of Oncology Sremska Kamenica
🇷🇸
Kamenica, Serbia
Sahlgrenska University Hospital
🇸🇪
Göteborg, Sweden
Bristol Haematology and Oncology Centre
🇬🇧
Bristol, United Kingdom
Royal Marsden Hospital
🇬🇧
London, United Kingdom
Tula Region Oncology Dispensary
🇷🇺
Tula, Russian Federation
Voronezh Region Clinical Oncology Dispensary
🇷🇺
Voronezh, Russian Federation
Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
🇵🇱
Olsztyn, Poland
Dolnoslaskie Centrum Onkologii
🇵🇱
Wroclaw, Poland
Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej
🇵🇱
Warszawa, Poland
Institute for Oncology and Radiology
🇷🇸
Belgrade, Serbia
Royal Surrey County
🇬🇧
Guildford, Surrey, United Kingdom
Markusovszky County Hospital
🇭🇺
Szombathely, Hungary
St-Luc University Hospital
🇧🇪
Brussels, Belgium
CHNDRF
🇧🇪
Charleroi, Belgium
"University Hospital
🇧🇪
Gent, Belgium
Centro Goiano de Oncologia
🇧🇷
Goiânia, Brazil
BioCancer
🇧🇷
Belo Horizonte, Brazil
Fundação Amaral Carvalho
🇧🇷
Jaú, Brazil
CliniOnco
🇧🇷
Porto Alegre, Brazil
Hospital de Clínicas de Porto Alegre
🇧🇷
Porto Alegre, Brazil
Hospital Araújo Jorge
🇧🇷
Goiânia, Brazil
Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia
🇧🇷
Santo André, Brazil
Santo Andre Diag e Tratamentos
🇧🇷
Santo André, Brazil
Hospital Heliópolis
🇧🇷
São Paulo, Brazil
UNIFESP
🇧🇷
São Paulo - SP, Brazil
BC Cancer Agency
🇨🇦
Vancouver, British Colombia, Canada
Centre Oscar Lambrette
🇫🇷
Lille Cedex, France
Hôpital Tenon - department of medical oncology
🇫🇷
Paris Cedex, France
Uzsoki Hospital Budapest
🇭🇺
Budapest, Hungary
University of Debrecen
🇭🇺
Debrecen, Hungary
University of Szeged
🇭🇺
Szeged, Hungary
Petz Aladár
🇭🇺
Gyor, Hungary
Szabolcs-Szatmar-Bereg County Hospital
🇭🇺
Nyiregyhaza, Hungary
Klaipeda Hospital
🇱🇹
Klaipeda, Lithuania
Zala County Hospital
🇭🇺
Zalaegerszeg-Pózca, Hungary
Beskidzkie Centrum Onkologii
🇵🇱
Bielsko-Biala, Poland
Vilnius University
🇱🇹
Vilnius, Lithuania
Belgorod Regional Oncology Dispensary
🇷🇺
Belgorod, Russian Federation
Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada
London Regional Cancer Program
🇨🇦
London, Ontario, Canada
Centre Antoine Lacassagne
🇫🇷
Nice, France
Newcastle General Hospital
🇬🇧
Newcastle, United Kingdom
Hospital Erasto Gaertner
🇧🇷
Curitiba, Brazil
Centro de Oncologia - InRad HCFMUSP
🇧🇷
São Paulo, Brazil
Hôpital Beaujon- department of medical oncology
🇫🇷
Clichy, France
Institut Gustave Roussy
🇫🇷
Villejuif Cedex, France
Semmelweis University
🇭🇺
Budapest, Hungary
Szent Borbála County Hospital Oncology Department
🇭🇺
Tatabánya, Hungary
Samodzielny Publiczny Szpital Kiniczny Nr1
🇵🇱
Gdansk, Poland
Katedra i Onkologii Collegium
🇵🇱
Krakow, Poland
Centrum Onkologii
🇵🇱
Lublin, Poland
Szpital Specjalistyczny im. Rydygiera
🇵🇱
Krakow, Poland
North-Estonian Regional Hospital
🇪🇪
Tallinn, Estonia
Tom Baker Cancer Centre
🇨🇦
Calgary, Alberta, Canada