Zalutumumab in Non-curable Patients With SCCHN

Head and Neck Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542308
• Other study ID #: GEN205
• Status: Completed
• Phase: Phase 2
• Start date: January 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2023
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Neoplasms, Squamous Cell
• Squamous Cell Cancer

Intervention

Drug:
• Zalutumumab
Individual dose titration weekly i.v. doses

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Austria	Universitätsklinik für Innere Medizin III	Salzburg
Austria	AKH Wien	Wien
Chile	Instituto Clinico Oncologico del Sur ICOS	Temuco
Chile	Hospital Carlos Van Buren de Valparaiso	Valparaiso
Chile	Instituto Oncologico	Viña del Mar
Colombia	Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A	Bogota
Colombia	Hospital Pablo Tobon Uribe	Medellin
Colombia	Oncomedica S.A.	Montería
Colombia	Oncólogos del Occidente S.A.	Pereira
Czechia	Facultni Nemocnice Hradec Kralove	Hradec Králové
Czechia	Nemocnice Jihlava	Jihlava
Czechia	Facultni Nemocnice Na Bulovce	Prague
Czechia	Veseobecna Fakultni Nemocnice	Prague
Germany	Universitätsklinikum Essen	Essen
Germany	Klinikum der Johann Wolfgang Goethe Universität	Frankfurt am Main
Germany	Uniklinik Freiburg	Freiburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Medizinische Universitätsklinik Lübeck	Lübeck
Germany	Südharz-Krankenhaus Nordhausen gGmbH	Nordhausen
Israel	Soroka Medical Center	Beer Sheva
Israel	Rambam Medial Center	Haifa
Israel	Shaare-Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat-Gan
Israel	Sourasky Medical Center	Tel-Aviv
Italy	Istituto Europea di Oncologia	Milan
Italy	Istituto Nazionale Tumori	Milan
Italy	Azienda Ospedaliera Valtellina e Valchiavenna	Sondrio
Peru	Hospital Goyeneche	Arequipa
Peru	Hospital Nacional Carlos Alberto Seguin Escobedo	Arequipa
Peru	Hospital Nacional Almanzor Aguinaga Asenjo	Lambayeque
Peru	Hospital Central FAP	Lima
Peru	Hospital Nacional Guillermo Almenara Irigoyen	Lima
Portugal	IPO Coimbra	Coimbra
Portugal	IPO Lisboa	Lisboa
Portugal	IPO Porto	Porto
Slovakia	Narodny onkologicky ustav	Bratislava
Slovakia	FN Trnava	Trnava
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Mountain States Tumor Institute	Boise	Idaho
United States	University Of Chicago Medical Center	Chicago	Illinois
United States	Baylor University Medical Center	Dallas	Texas
United States	Henry Ford Health Systems	Detroit	Michigan
United States	Ft. Wayne Medical Oncology/Hematology, Inc	Fort Wayne	Indiana
United States	Loma Linda University Cancer Institute	Loma Linda	California
United States	Oregon Health and Science University	Portland	Oregon
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Countries where clinical trial is conducted

United States,  Austria,  Chile,  Colombia,  Czechia,  Germany,  Israel,  Italy,  Peru,  Portugal,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS was defined as time from start of treatment until date of death of any cause.	From randomization until death, assessed up to 21 months
Secondary	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.	During treatment and two weeks after end of treatment, assessed up to 21 months.
Secondary	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.	During treatment and two weeks after end of treatment, assessed up to 21 months
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from start of treatment until disease progression or death.	During treatment and two weeks after end of treatment, assessed up to 21 months