Spots Global Cancer Trial Database for Zalutumumab in Patients With Non-curable Head and Neck Cancer
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Trial Identification
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 ID: NCT00382031
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, , Belgium
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
UNIFESP, São Paulo - SP, , Brazil
Centro de Oncologia - InRad HCFMUSP, São Paulo, , Brazil
Hospital Heliópolis, São Paulo, , Brazil
IBCC - Instituto Brasileiro de Combate ao Câncer, São Paulo, , Brazil
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, , Canada
North-Estonian Regional Hospital, Tallinn, , Estonia
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, , France
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, , Hungary
Klaipeda Hospital, Klaipeda, , Lithuania
Vilnius University, Vilnius, , Lithuania
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
Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, , Poland
Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej, Warszawa, , Poland
Dolnoslaskie Centrum Onkologii, Wroclaw, , Poland
Szpital Wojewódzki SP ZOZ, Zielona Góra, , Poland
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, , Russian Federation
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, , Serbia
Sahlgrenska University Hospital, Göteborg, , Sweden
Lund University Hospital, Lund, , Sweden
Musgrove Park Hospital, Taunton, Somerset, United Kingdom
Royal Surrey County, Guildford, Surrey, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
The Beatson West of Scotland Centre, Glasgow, , 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
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
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