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Zalutumumab in Non-curable Patients With SCCHN

Primary Purpose

Head and Neck Cancer, Squamous Cell Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zalutumumab
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 prior chemotherapy regimens
  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

Sites / Locations

  • University of Alabama at Birmingham
  • Loma Linda University Cancer Institute
  • Moffitt Cancer Center
  • Mountain States Tumor Institute
  • University Of Chicago Medical Center
  • Ft. Wayne Medical Oncology/Hematology, Inc
  • Henry Ford Health Systems
  • Oregon Health and Science University
  • Baylor University Medical Center
  • Medizinische Universität Graz
  • Universitätsklinik für Innere Medizin III
  • AKH Wien
  • Instituto Clinico Oncologico del Sur ICOS
  • Hospital Carlos Van Buren de Valparaiso
  • Instituto Oncologico
  • Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A
  • Hospital Pablo Tobon Uribe
  • Oncomedica S.A.
  • Oncólogos del Occidente S.A.
  • Facultni Nemocnice Hradec Kralove
  • Nemocnice Jihlava
  • Veseobecna Fakultni Nemocnice
  • Facultni Nemocnice Na Bulovce
  • Universitätsklinikum Essen
  • Klinikum der Johann Wolfgang Goethe Universität
  • Uniklinik Freiburg
  • Universitätsklinikum Heidelberg
  • Medizinische Universitätsklinik Lübeck
  • Südharz-Krankenhaus Nordhausen gGmbH
  • Soroka Medical Center
  • Rambam Medial Center
  • Shaare-Zedek Medical Center
  • Rabin Medical Center
  • Sheba Medical Center
  • Sourasky Medical Center
  • Istituto Nazionale Tumori
  • Istituto Europea di Oncologia
  • Azienda Ospedaliera Valtellina e Valchiavenna
  • Hospital Goyeneche
  • Hospital Nacional Carlos Alberto Seguin Escobedo
  • Hospital Nacional Almanzor Aguinaga Asenjo
  • Hospital Central FAP
  • Hospital Nacional Guillermo Almenara Irigoyen
  • IPO Coimbra
  • IPO Lisboa
  • IPO Porto
  • Narodny onkologicky ustav
  • FN Trnava

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zalutumumab 4-16 mg/kg

Arm Description

Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS was defined as time from start of treatment until date of death of any cause.

Secondary Outcome Measures

Objective Tumour Response
Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). 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. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
Duration of Response
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Progression Free Survival (PFS)
PFS is defined as the time from start of treatment until disease progression or death.

Full Information

First Posted
October 10, 2007
Last Updated
August 2, 2023
Sponsor
Genmab
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1. Study Identification

Unique Protocol Identification Number
NCT00542308
Brief Title
Zalutumumab in Non-curable Patients With SCCHN
Official Title
An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2011 (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
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

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
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zalutumumab 4-16 mg/kg
Arm Type
Experimental
Arm Description
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Intervention Type
Drug
Intervention Name(s)
Zalutumumab
Intervention Description
Individual dose titration weekly i.v. doses
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as time from start of treatment until date of death of any cause.
Time Frame
From randomization until death, assessed up to 21 months
Secondary Outcome Measure Information:
Title
Objective Tumour Response
Description
Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). 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. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
Time Frame
During treatment and two weeks after end of treatment, assessed up to 21 months.
Title
Duration of Response
Description
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Time Frame
During treatment and two weeks after end of treatment, assessed up to 21 months
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from start of treatment until disease progression or death.
Time Frame
During treatment and two weeks after end of treatment, assessed up to 21 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 prior chemotherapy regimens Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors Past or current malignancy other than SCCHN, except for certain other cancer diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steen Lisby, MD
Organizational Affiliation
Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0012
Country
United States
Facility Name
Loma Linda University Cancer Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
University Of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ft. Wayne Medical Oncology/Hematology, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
Henry Ford Health Systems
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Medizinische Universität Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin III
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Instituto Clinico Oncologico del Sur ICOS
City
Temuco
Country
Chile
Facility Name
Hospital Carlos Van Buren de Valparaiso
City
Valparaiso
Country
Chile
Facility Name
Instituto Oncologico
City
Viña del Mar
Country
Chile
Facility Name
Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A
City
Bogota
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
Country
Colombia
Facility Name
Oncomedica S.A.
City
Montería
Country
Colombia
Facility Name
Oncólogos del Occidente S.A.
City
Pereira
Country
Colombia
Facility Name
Facultni Nemocnice Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Veseobecna Fakultni Nemocnice
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Facultni Nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe Universität
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Uniklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Medizinische Universitätsklinik Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Südharz-Krankenhaus Nordhausen gGmbH
City
Nordhausen
ZIP/Postal Code
99734
Country
Germany
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medial Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Shaare-Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Istituto Nazionale Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europea di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera Valtellina e Valchiavenna
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Hospital Goyeneche
City
Arequipa
Country
Peru
Facility Name
Hospital Nacional Carlos Alberto Seguin Escobedo
City
Arequipa
Country
Peru
Facility Name
Hospital Nacional Almanzor Aguinaga Asenjo
City
Lambayeque
Country
Peru
Facility Name
Hospital Central FAP
City
Lima
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen
City
Lima
Country
Peru
Facility Name
IPO Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
IPO Lisboa
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
IPO Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
FN Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24714973
Citation
Saloura V, Cohen EE, Licitra L, Billan S, Dinis J, Lisby S, Gauler TC. An open-label single-arm, phase II trial of zalutumumab, a human monoclonal anti-EGFR antibody, in patients with platinum-refractory squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2014 Jun;73(6):1227-39. doi: 10.1007/s00280-014-2459-z. Epub 2014 Apr 9.
Results Reference
derived

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Zalutumumab in Non-curable Patients With SCCHN

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