300
Participants
Start Date
May 31, 2012
Primary Completion Date
May 31, 2015
Study Completion Date
May 31, 2017
Cisplatin, 5-FU
"Arm A: Cisplatin 80 mg/m2 IV infusion over 2 hours on Day 1, followed by 5-FU 1000 mg/m2 IV daily as continuous infusion over 24 hours, Day 1-4.~Chemotherapy will be administered every 3 weeks until progression of disease or any other reason for treatment withdrawal is fulfilled."
Panitumumab
"Arm B: Cisplatin 80 mg/m2 IV infusion over 2 hours on Day 1, followed by 5-FU 1000 mg/m2 IV daily as continuous infusion over 24 hours, Day 1-4.~Panitumumab will be administered on Day 1 of each treatment cycle at a dose of 9 mg/kg prior to administration of chemotherapy.~Each treatment cycle is defined as 21 days. Patients are treated until progression of disease occurs or any other reason for treatment withdrawal is fulfilled."
Johannes-Gutenberg-Universität Mainz, I. Medizinische Klinik und Poliklinik, Mainz
Collaborators (2)
Amgen
INDUSTRY
Assign Data Management and Biostatistics GmbH
OTHER
Assign Clinical Research GmbH
OTHER
AIO-Studien-gGmbH
OTHER