To determine whether adding panitumumab, an antibody against the epidermal growth factor receptor (EGFR), to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the duration of survival of patients with advanced stomach and oesophageal cancer.
Multicentre phase III, open labelled, randomised controlled trial. Randomisation will be 1:1 Arm A EOX and Arm B EOX + panitumumab. There will be a pilot phase II study of which the first 200 patients will be randomised and the primary endpoint for interim analysis will be when these patients have completed 6 months follow-up
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
574
epirubicin 50mg/m(2) IV on day 1 oxaliplatin 130mg/m(2) IV on day 1 with hydration capecitabine 1250mg/m(2)/day PO in two divided doses continuously from days 1-21
epirubicin 50mg/m(2) IV on day 1 oxaliplatin 100mg/m(2) IV on day 1 with hydration capecitabine 1000mg/m(2)/day PO in two divided doses continuously from days 1-21 panitumumab -9 mg/kg every 21 days
Bournemouth
Bournemouth, United Kingdom
St Luke's Guildford
Guildford, United Kingdom
Royal Liverpool
Liverpool, United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
Overall survival
Study closed early due to lack of efficacy
Time frame: Early termination
response rate, toxicity, quality of life and PFS
Study closed early due to lack of efficacy
Time frame: Early termination
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Clatterbridge Oncology Centre
Metropolitan Borough of Wirral, United Kingdom
Newcastle
Newcastle, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom