Head and Neck CancerPhase 3NCT00382031
Zalutumumab in Patients With Non-curable Head and Neck Cancer
A Phase 3 study testing Zalutumumab in people with Head and Neck Cancer and Squamous Cell Cancer, run by Genmab at 82 sites in 12 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Cancer
- What is being tested?
- Zalutumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 82 sitesin 12 countries
- Study dates
- Nov 2006to Aug 2011
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
82 sites in 12 countries.
82 sites in 12 countries
Russia17 sites
Belgorod Regional Oncology Dispensary
Belgorod
Regional Oncology Dispensary
Chelyabinsk
Republican Clinical Oncology Dispensary
Izhevsk
Kursk Regional Oncology Dispencary
Kursk
Kursk Regional Oncology Dispensary
Kursk
City Clinincal Oncology Dispensary #1
Moscow
Moscow Research Institute of Oncology
Moscow
NUZ Semashko Central Clinical Hospital No2 OAO
Moscow
Russian Oncology Research Center n.a. Blokhin
Moscow
GUZ NO Oncology Dispensary
Nizhiy Novgorod
Medical Radiological Research Center
Obninsk
St. Petersburg State Medical University
Saint Petersburg
Sochi Oncology Center
Sochi
Stavropol Regional Clinical Oncology Dispensary
Stavropol
Tula Region Oncology Dispensary
Tula
GUZ Volgograd Region Clinical Oncology Dispensary No1
Volgograd
Voronezh Region Clinical Oncology Dispensary
Voronezh
Brazil13 sites
BioCancer
Belo Horizonte
Hospital Erasto Gaertner
Curitiba
Centro Goiano de Oncologia
Goiânia
Hospital Araújo Jorge
Goiânia
Fundação Amaral Carvalho
Jaú
CliniOnco
Porto Alegre
Hospital de Clínicas de Porto Alegre
Porto Alegre
Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia
Santo André
Santo Andre Diag e Tratamentos
Santo André
Centro de Oncologia - InRad HCFMUSP
São Paulo
Hospital Heliópolis
São Paulo
IBCC - Instituto Brasileiro de Combate ao Câncer
São Paulo
UNIFESP
São Paulo - SP
Hungary9 sites
Semmelweis University
Budapest
Uzsoki Hospital Budapest
Budapest
University of Debrecen
Debrecen
Petz Aladár
Győr
Szabolcs-Szatmar-Bereg County Hospital
Nyíregyháza
University of Szeged
Szeged
Markusovszky County Hospital
Szombathely
Szent Borbála County Hospital Oncology Department
Tatabánya
Zala County Hospital
Zalaegerszeg-Pózca
Poland9 sites
Beskidzkie Centrum Onkologii
Bielsko-Biala
Samodzielny Publiczny Szpital Kiniczny Nr1
Gdansk
Katedra i Onkologii Collegium
Krakow
Szpital Specjalistyczny im. Rydygiera
Krakow
Centrum Onkologii
Lublin
Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn
Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej
Warsaw
Dolnoslaskie Centrum Onkologii
Wroclaw
Szpital Wojewódzki SP ZOZ
Zielona Góra
United Kingdom9 sites
Bristol Haematology and Oncology Centre
Bristol
The Beatson West of Scotland Centre
Glasgow
Royal Surrey County
Guildford, Surrey
Royal Marsden Hospital
London
Christie Hospital
Manchester
Newcastle General Hospital
Newcastle
Weston Park Hospital
Sheffield
Musgrove Park Hospital
Taunton, Somerset
New Cross Hospital
Wolverhampton
Belgium6 sites
University Hospital Antwerp
Antwerp
St-Luc University Hospital
Brussels
CHNDRF
Charleroi
"University Hospital
Ghent
University Hospital Leuven
Leuven
Cliniques Saint Pierre
Ottignies
Canada5 sites
Tom Baker Cancer Centre
Calgary, Alberta
Cross Cancer Institute
Edmonton, Alberta
London Regional Cancer Program
London, Ontario
Princess Margaret Hospital
Toronto, Ontario
BC Cancer Agency
Vancouver, British Colombia
France5 sites
Hôpital Beaujon- department of medical oncology
Clichy
Centre Oscar Lambrette
Lille
Centre Antoine Lacassagne
Nice
Hôpital Tenon - department of medical oncology
Paris
Institut Gustave Roussy
Villejuif
Serbia4 sites
Institute for Oncology and Radiology
Belgrade
Military Medical Academy
Belgrade
Institute of Oncology Sremska Kamenica
Kamenica
Clinic of Maxillofacial Surgery Nis
Niš
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg
Lund University Hospital
Lund
About this study
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
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
Read the 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.
- Conditions
- Head and Neck Cancer, Squamous Cell Cancer
- Being tested
- Zalutumumab, Control
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZalutumumabDrug
Also called Zalutumumab in combination with Best Supportive Care
Individual dose titration weekly i.v doses
ControlOther
Also called Best Supportive Care
Best Supportive Care
| Study group | Role | What they receive |
|---|---|---|
| zalutumumab | Active comparator | Zalutumumab in combination with Best Supportive Care Receives: Drug: Zalutumumab; Other: Control |
| Control | Other | Best Supportive Care Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
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.
Measured: From randomization until death
Secondary outcomes (3)
Objective Tumor Response
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
Measured: From date of randomization until the date of death from any cause, assessed up to 41 months.
Duration of Response
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.
Measured: Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.
Progression Free Survival (PFS)
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.
Measured: From randomization until disease progression or death, assessed up to 41 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2009
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382031
- Sponsor's protocol ID
- Hx-EGFr-202
- Status last verified
- Aug 2013
- First submitted
- 27 Sep 2006
- Last updated
- 15 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21377930