NCT01040832 - EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | Biotech Hunter

Enrollment

107

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

January 31, 2012

Conditions

Squamous Cell Carcinoma of the Head and Neck Cancer

Interventions

DRUG

Cetuximab

Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] over 120 minutes followed by 250 mg/m\^2 intravenous infusion over 60 minutes) will be administered in 3-week treatment cycle until disease progression. The total treatment period will be approximately 18 months.

DRUG

EMD 1201081

EMD 1201081 weekly (0.32 milligram per kilogram \[mg/kg\] by subcutaneous injection) will be administered in 3-week treatment cycle until disease progression. Subjects who will discontinue cetuximab due to toxicity in cetuximab monotherapy, could continue to receive EMD 1201081 monotherapy until disease progression. The total treatment period will be approximately 18 months.

Trial Locations (35)

Unknown

University of Colorado Cancer Center, Aurora

University of Kentucky, Markey Cancer Center, Lexington

MGH Massachusetts General Hospital, Boston

Montefiore Medical Center Oncology, The Bronx

Research Site, Brussels

UZ Gent, Ghent

Research Site, Wilrijk

Cliniques Universitaires Mont-Godinne, Yvoir

Research Site, Brno

Research Site, Kladno

Research Site, Pardubice

Ustav radiacni onkologie Fakultni nemacnice Na Bulovce, Prague

Research Site, Montpellier

Research Site, Villejuif

Research Site, Győr

Research Site, Kecskemét

Research Site, Miskolc

Research Site, Nyiregyahaza

Szegedi Tudomayegyetem Altalanos Orvostudomanyi Kar Onkoterapias Klinika, Szeged

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok

Zala Megyei Kohaz Kulsokorhaz Onkologia Osztaly, Zalaegerszeg

SPZOZ Centrum Onkologi Liemi Lubelskiej, II Odzial Radioterapiii z pododdzialem Chemioterpii, Lublin

Zaklad Opleki Zdrowotnej MSWIA z Warminsko-Mazurskim Centrum Onkologil, Oddziat Chemioterapli, Olsztyn

Centrum Onkologi - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Glowy i Szyi (NCI), Warsaw

Onkologicky ustav Sv. Alzbety, Bratislava

Nemocnice s poliklinikou Zilina, Žilina

Velindre Cancer Centre, Cardiff

Research Site, Conventry

MHCW, Coventry

St. James' University Hospital, Leeds

Research Site, London

The Christie NHS FT, Manchester

Research Site, Newcastle upon Tyne

Weston Park Hospital, Sheffield

Southampton University Hospitals NHS Trust, Southampton