Zalutumumab in Patients With Non-curable Head and Neck Cancer

Last updated: August 9, 2013
Sponsor: Genmab
Overall Status: Completed

Phase

3

Condition

Nasopharyngeal Cancer

Lung Cancer

Head And Neck Cancer

Treatment

N/A

Clinical Study ID

NCT00382031
Hx-EGFr-202
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and Females age ≥ 18 years

  2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oralcavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy

  3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion

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

Study Design

Total Participants: 286
Study Start date:
November 01, 2006
Estimated Completion Date:
August 31, 2011

Study 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.

Connect with a study center

  • University Hospital Antwerp

    Antwerp,
    Belgium

    Site Not Available

  • St-Luc University Hospital

    Brussels,
    Belgium

    Site Not Available

  • CHNDRF

    Charleroi,
    Belgium

    Site Not Available

  • "University Hospital

    Gent,
    Belgium

    Site Not Available

  • University Hospital Leuven

    Leuven,
    Belgium

    Site Not Available

  • Cliniques Saint Pierre

    Ottignies,
    Belgium

    Site Not Available

  • BioCancer

    Belo Horizonte,
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner

    Curitiba,
    Brazil

    Site Not Available

  • Centro Goiano de Oncologia

    Goiânia,
    Brazil

    Site Not Available

  • Centro Goiano de Oncologia

    Goiânia,
    Brazil

    Site Not Available

  • Hospital Araújo Jorge

    Goiânia,
    Brazil

    Site Not Available

  • Fundação Amaral Carvalho

    Jaú,
    Brazil

    Site Not Available

  • Fundação Amaral Carvalho

    Jaú,
    Brazil

    Site Not Available

  • CliniOnco

    Porto Alegre,
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre,
    Brazil

    Site Not Available

  • Santo Andre Diag e Tratamentos

    Santo André,
    Brazil

    Site Not Available

  • Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia

    Santo André,
    Brazil

    Site Not Available

  • Santo Andre Diag e Tratamentos

    Santo André,
    Brazil

    Site Not Available

  • Centro de Oncologia - InRad HCFMUSP

    São Paulo,
    Brazil

    Site Not Available

  • Unifesp

    São Paulo - SP,
    Brazil

    Site Not Available

  • Centro de Oncologia - InRad HCFMUSP

    São Paulo,
    Brazil

    Site Not Available

  • Hospital Heliópolis

    São Paulo,
    Brazil

    Site Not Available

  • IBCC - Instituto Brasileiro de Combate ao Câncer

    São Paulo,
    Brazil

    Site Not Available

  • UNIFESP

    São Paulo - SP,
    Brazil

    Site Not Available

  • Tom Baker Cancer Centre

    Calgary, Alberta
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta
    Canada

    Site Not Available

  • London Regional Cancer Program

    London, Ontario
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario
    Canada

    Site Not Available

  • BC Cancer Agency

    Vancouver, British Colombia,
    Canada

    Site Not Available

  • North-Estonian Regional Hospital

    Tallinn,
    Estonia

    Site Not Available

  • Hôpital Beaujon- department of medical oncology

    Clichy,
    France

    Site Not Available

  • Centre Oscar Lambrette

    Lille Cedex,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice,
    France

    Site Not Available

  • Hôpital Tenon - department of medical oncology

    Paris Cedex,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif Cedex,
    France

    Site Not Available

  • Semmelweis University

    Budapest,
    Hungary

    Site Not Available

  • Uzsoki Hospital Budapest

    Budapest,
    Hungary

    Site Not Available

  • University of Debrecen

    Debrecen,
    Hungary

    Site Not Available

  • Petz Aladár

    Gyor,
    Hungary

    Site Not Available

  • Szabolcs-Szatmar-Bereg County Hospital

    Nyiregyhaza,
    Hungary

    Site Not Available

  • University of Szeged

    Szeged,
    Hungary

    Site Not Available

  • Markusovszky County Hospital

    Szombathely,
    Hungary

    Site Not Available

  • Szent Borbála County Hospital Oncology Department

    Tatabánya,
    Hungary

    Site Not Available

  • Szent Borbála County Hospital Oncology Department

    Tatabánya,
    Hungary

    Site Not Available

  • Zala County Hospital

    Zalaegerszeg-Pózca,
    Hungary

    Site Not Available

  • Zala County Hospital

    Zalaegerszeg-Pózca,
    Hungary

    Site Not Available

  • Klaipeda Hospital

    Klaipeda,
    Lithuania

    Site Not Available

  • Vilnius University

    Vilnius,
    Lithuania

    Site Not Available

  • Beskidzkie Centrum Onkologii

    Bielsko-Biala,
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kiniczny Nr1

    Gdansk,
    Poland

    Site Not Available

  • Katedra i Onkologii Collegium

    Krakow,
    Poland

    Site Not Available

  • Szpital Specjalistyczny im. Rydygiera

    Krakow,
    Poland

    Site Not Available

  • Centrum Onkologii

    Lublin,
    Poland

    Site Not Available

  • Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn,
    Poland

    Site Not Available

  • Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej

    Warszawa,
    Poland

    Site Not Available

  • Dolnoslaskie Centrum Onkologii

    Wroclaw,
    Poland

    Site Not Available

  • Szpital Wojewódzki SP ZOZ

    Zielona Góra,
    Poland

    Site Not Available

  • Szpital Wojewódzki SP ZOZ

    Zielona Góra,
    Poland

    Site Not Available

  • Belgorod Regional Oncology Dispensary

    Belgorod,
    Russian Federation

    Site Not Available

  • Regional Oncology Dispensary

    Chelyabinsk,
    Russian Federation

    Site Not Available

  • Republican Clinical Oncology Dispensary

    Izhevsk,
    Russian Federation

    Site Not Available

  • Kursk Regional Oncology Dispencary

    Kursk,
    Russian Federation

    Site Not Available

  • Kursk Regional Oncology Dispensary

    Kursk,
    Russian Federation

    Site Not Available

  • City Clinincal Oncology Dispensary #1

    Moscow,
    Russian Federation

    Site Not Available

  • Moscow Research Institute of Oncology

    Moscow,
    Russian Federation

    Site Not Available

  • NUZ Semashko Central Clinical Hospital No2 OAO

    Moscow,
    Russian Federation

    Site Not Available

  • Russian Oncology Research Center n.a. Blokhin

    Moscow,
    Russian Federation

    Site Not Available

  • GUZ NO Oncology Dispensary

    Nizhiy Novgorod,
    Russian Federation

    Site Not Available

  • Medical Radiological Research Center

    Obninsk,
    Russian Federation

    Site Not Available

  • Sochi Oncology Center

    Sochi,
    Russian Federation

    Site Not Available

  • St. Petersburg State Medical University

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Stavropol Regional Clinical Oncology Dispensary

    Stavropol,
    Russian Federation

    Site Not Available

  • Tula Region Oncology Dispensary

    Tula,
    Russian Federation

    Site Not Available

  • GUZ Volgograd Region Clinical Oncology Dispensary No1

    Volgograd,
    Russian Federation

    Site Not Available

  • Voronezh Region Clinical Oncology Dispensary

    Voronezh,
    Russian Federation

    Site Not Available

  • Institute for Oncology and Radiology

    Belgrade,
    Serbia

    Site Not Available

  • Military Medical Academy

    Belgrade,
    Serbia

    Site Not Available

  • Institute of Oncology Sremska Kamenica

    Kamenica,
    Serbia

    Site Not Available

  • Clinic of Maxillofacial Surgery Nis

    Nis,
    Serbia

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg,
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg,
    Sweden

    Site Not Available

  • Lund University Hospital

    Lund,
    Sweden

    Site Not Available

  • Musgrove Park Hospital

    Taunton, Somerset
    United Kingdom

    Site Not Available

  • Royal Surrey County

    Guildford, Surrey
    United Kingdom

    Site Not Available

  • Bristol Haematology and Oncology Centre

    Bristol,
    United Kingdom

    Site Not Available

  • The Beatson West of Scotland Centre

    Glasgow,
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    London,
    United Kingdom

    Site Not Available

  • Christie Hospital

    Manchester,
    United Kingdom

    Site Not Available

  • Newcastle General Hospital

    Newcastle,
    United Kingdom

    Site Not Available

  • Weston Park Hospital

    Sheffield,
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton,
    United Kingdom

    Site Not Available

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