Back to resultsZalutumumab in Patients With Non-curable Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Squamous Cell Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zalutumumab
Control
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
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
Sites / Locations
- University Hospital Antwerp
- St-Luc University Hospital
- CHNDRF
- "University Hospital
- University Hospital Leuven
- Cliniques Saint Pierre
- BioCancer
- Hospital Erasto Gaertner
- Centro Goiano de Oncologia
- Hospital Araújo Jorge
- Fundação Amaral Carvalho
- CliniOnco
- Hospital de Clínicas de Porto Alegre
- Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia
- Santo Andre Diag e Tratamentos
- UNIFESP
- Centro de Oncologia - InRad HCFMUSP
- Hospital Heliópolis
- IBCC - Instituto Brasileiro de Combate ao Câncer
- Tom Baker Cancer Centre
- Cross Cancer Institute
- London Regional Cancer Program
- Princess Margaret Hospital
- BC Cancer Agency
- North-Estonian Regional Hospital
- Hôpital Beaujon- department of medical oncology
- Centre Oscar Lambrette
- Centre Antoine Lacassagne
- Hôpital Tenon - department of medical oncology
- Institut Gustave Roussy
- Semmelweis University
- Uzsoki Hospital Budapest
- University of Debrecen
- Petz Aladár
- Szabolcs-Szatmar-Bereg County Hospital
- University of Szeged
- Markusovszky County Hospital
- Szent Borbála County Hospital Oncology Department
- Zala County Hospital
- Klaipeda Hospital
- Vilnius University
- Beskidzkie Centrum Onkologii
- Samodzielny Publiczny Szpital Kiniczny Nr1
- Katedra i Onkologii Collegium
- Szpital Specjalistyczny im. Rydygiera
- Centrum Onkologii
- Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
- Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej
- Dolnoslaskie Centrum Onkologii
- Szpital Wojewódzki SP ZOZ
- Belgorod Regional Oncology Dispensary
- Regional Oncology Dispensary
- Republican Clinical Oncology Dispensary
- Kursk Regional Oncology Dispencary
- Kursk Regional Oncology Dispensary
- City Clinincal Oncology Dispensary #1
- Moscow Research Institute of Oncology
- NUZ Semashko Central Clinical Hospital No2 OAO
- Russian Oncology Research Center n.a. Blokhin
- GUZ NO Oncology Dispensary
- Medical Radiological Research Center
- Sochi Oncology Center
- St. Petersburg State Medical University
- Stavropol Regional Clinical Oncology Dispensary
- Tula Region Oncology Dispensary
- GUZ Volgograd Region Clinical Oncology Dispensary No1
- Voronezh Region Clinical Oncology Dispensary
- Institute for Oncology and Radiology
- Military Medical Academy
- Institute of Oncology Sremska Kamenica
- Clinic of Maxillofacial Surgery Nis
- Sahlgrenska University Hospital
- Lund University Hospital
- Musgrove Park Hospital
- Royal Surrey County
- Bristol Haematology and Oncology Centre
- The Beatson West of Scotland Centre
- Royal Marsden Hospital
- Christie Hospital
- Newcastle General Hospital
- Weston Park Hospital
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
zalutumumab
Control
Arm Description
Zalutumumab in combination with Best Supportive Care
Best Supportive Care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00382031
Brief Title
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
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Squamous Cell Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
zalutumumab
Arm Type
Active Comparator
Arm Description
Zalutumumab in combination with Best Supportive Care
Arm Title
Control
Arm Type
Other
Arm Description
Best Supportive Care
Intervention Type
Drug
Intervention Name(s)
Zalutumumab
Other Intervention Name(s)
Zalutumumab in combination with Best Supportive Care
Intervention Description
Individual dose titration weekly i.v doses
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Best Supportive Care
Intervention Description
Best Supportive Care
Primary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
From randomization until death
Secondary Outcome Measure Information:
Title
Objective Tumor Response
Description
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
Time Frame
From date of randomization until the date of death from any cause, assessed up to 41 months.
Title
Duration of Response
Description
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 Frame
Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
From randomization until disease progression or death, assessed up to 41 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
Country
Belgium
Facility Name
St-Luc University Hospital
City
Brussels
Country
Belgium
Facility Name
CHNDRF
City
Charleroi
Country
Belgium
Facility Name
"University Hospital
City
Gent
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
Country
Belgium
Facility Name
Cliniques Saint Pierre
City
Ottignies
Country
Belgium
Facility Name
BioCancer
City
Belo Horizonte
Country
Brazil
Facility Name
Hospital Erasto Gaertner
City
Curitiba
Country
Brazil
Facility Name
Centro Goiano de Oncologia
City
Goiânia
Country
Brazil
Facility Name
Hospital Araújo Jorge
City
Goiânia
Country
Brazil
Facility Name
Fundação Amaral Carvalho
City
Jaú
Country
Brazil
Facility Name
CliniOnco
City
Porto Alegre
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia
City
Santo André
Country
Brazil
Facility Name
Santo Andre Diag e Tratamentos
City
Santo André
Country
Brazil
Facility Name
UNIFESP
City
São Paulo - SP
Country
Brazil
Facility Name
Centro de Oncologia - InRad HCFMUSP
City
São Paulo
Country
Brazil
Facility Name
Hospital Heliópolis
City
São Paulo
Country
Brazil
Facility Name
IBCC - Instituto Brasileiro de Combate ao Câncer
City
São Paulo
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
BC Cancer Agency
City
Vancouver, British Colombia
Country
Canada
Facility Name
North-Estonian Regional Hospital
City
Tallinn
Country
Estonia
Facility Name
Hôpital Beaujon- department of medical oncology
City
Clichy
Country
France
Facility Name
Centre Oscar Lambrette
City
Lille Cedex
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
Hôpital Tenon - department of medical oncology
City
Paris Cedex
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
Country
France
Facility Name
Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Uzsoki Hospital Budapest
City
Budapest
Country
Hungary
Facility Name
University of Debrecen
City
Debrecen
Country
Hungary
Facility Name
Petz Aladár
City
Gyor
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg County Hospital
City
Nyiregyhaza
Country
Hungary
Facility Name
University of Szeged
City
Szeged
Country
Hungary
Facility Name
Markusovszky County Hospital
City
Szombathely
Country
Hungary
Facility Name
Szent Borbála County Hospital Oncology Department
City
Tatabánya
Country
Hungary
Facility Name
Zala County Hospital
City
Zalaegerszeg-Pózca
Country
Hungary
Facility Name
Klaipeda Hospital
City
Klaipeda
Country
Lithuania
Facility Name
Vilnius University
City
Vilnius
Country
Lithuania
Facility Name
Beskidzkie Centrum Onkologii
City
Bielsko-Biala
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kiniczny Nr1
City
Gdansk
Country
Poland
Facility Name
Katedra i Onkologii Collegium
City
Krakow
Country
Poland
Facility Name
Szpital Specjalistyczny im. Rydygiera
City
Krakow
Country
Poland
Facility Name
Centrum Onkologii
City
Lublin
Country
Poland
Facility Name
Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
City
Olsztyn
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej
City
Warszawa
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii
City
Wroclaw
Country
Poland
Facility Name
Szpital Wojewódzki SP ZOZ
City
Zielona Góra
Country
Poland
Facility Name
Belgorod Regional Oncology Dispensary
City
Belgorod
Country
Russian Federation
Facility Name
Regional Oncology Dispensary
City
Chelyabinsk
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary
City
Izhevsk
Country
Russian Federation
Facility Name
Kursk Regional Oncology Dispencary
City
Kursk
Country
Russian Federation
Facility Name
Kursk Regional Oncology Dispensary
City
Kursk
Country
Russian Federation
Facility Name
City Clinincal Oncology Dispensary #1
City
Moscow
Country
Russian Federation
Facility Name
Moscow Research Institute of Oncology
City
Moscow
Country
Russian Federation
Facility Name
NUZ Semashko Central Clinical Hospital No2 OAO
City
Moscow
Country
Russian Federation
Facility Name
Russian Oncology Research Center n.a. Blokhin
City
Moscow
Country
Russian Federation
Facility Name
GUZ NO Oncology Dispensary
City
Nizhiy Novgorod
Country
Russian Federation
Facility Name
Medical Radiological Research Center
City
Obninsk
Country
Russian Federation
Facility Name
Sochi Oncology Center
City
Sochi
Country
Russian Federation
Facility Name
St. Petersburg State Medical University
City
St. Petersburg
Country
Russian Federation
Facility Name
Stavropol Regional Clinical Oncology Dispensary
City
Stavropol
Country
Russian Federation
Facility Name
Tula Region Oncology Dispensary
City
Tula
Country
Russian Federation
Facility Name
GUZ Volgograd Region Clinical Oncology Dispensary No1
City
Volgograd
Country
Russian Federation
Facility Name
Voronezh Region Clinical Oncology Dispensary
City
Voronezh
Country
Russian Federation
Facility Name
Institute for Oncology and Radiology
City
Belgrade
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
Country
Serbia
Facility Name
Institute of Oncology Sremska Kamenica
City
Kamenica
Country
Serbia
Facility Name
Clinic of Maxillofacial Surgery Nis
City
Nis
Country
Serbia
Facility Name
Sahlgrenska University Hospital
City
Göteborg
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
Country
Sweden
Facility Name
Musgrove Park Hospital
City
Taunton
State/Province
Somerset
Country
United Kingdom
Facility Name
Royal Surrey County
City
Guildford
State/Province
Surrey
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
Country
United Kingdom
Facility Name
The Beatson West of Scotland Centre
City
Glasgow
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21377930
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.
Results Reference
derived
Learn more about this trial
Zalutumumab in Patients With Non-curable Head and Neck Cancer
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