Zalutumumab in Patients With Non-curable Head and Neck Cancer

August 9, 2013 updated by: Genmab

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: zalutumumab
Zalutumumab in combination with Best Supportive Care
Drug: Zalutumumab
Individual dose titration weekly i.v doses
Other Names:
  • Zalutumumab in combination with Best Supportive Care
Other: Control
Best Supportive Care
Other Names:
  • Best Supportive Care
Other: Control
Best Supportive Care
Other: Control
Best Supportive Care
Other Names:
  • Best Supportive Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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.
From randomization until death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Tumor Response
Time Frame: 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
From date of randomization until the date of death from any cause, assessed up to 41 months.
Duration of Response
Time Frame: 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.
Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.
Progression Free Survival (PFS)
Time Frame: 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.
From randomization until disease progression or death, assessed up to 41 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 27, 2006

First Submitted That Met QC Criteria

September 27, 2006

First Posted (Estimate)

September 28, 2006

Study Record Updates

Last Update Posted (Estimate)

October 15, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hx-EGFr-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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