Zalutumumab in Patients With Non-curable Head and Neck Cancer

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382031
• Other study ID #: Hx-EGFr-202
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2006
• Last updated: August 9, 2013
• Start date: November 2006
• Est. completion date: August 2011

Study information

• Verified date: August 2013
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPSweden: Medical Products AgencyRomania: National Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyLithuania: State Medicine Control Agency - Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesRussia: Pharmacological Committee, Ministry of HealthSpain: Spanish Agency of MedicinesPoland: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyEstonia: The State Agency of MedicineBulgaria: Ministry of HealthCanada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: August 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• 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 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Other:
• Control
Best Supportive Care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Countries where clinical trial is conducted

Belgium,  Brazil,  Canada,  Estonia,  France,  Hungary,  Lithuania,  Poland,  Russian Federation,  Serbia,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From randomization until death	No
Secondary	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	From date of randomization until the date of death from any cause, assessed up to 41 months.	No
Secondary	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.	Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.	No
Secondary	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.	From randomization until disease progression or death, assessed up to 41 months.	No