ATTAX 2

New approaches to the treatment of advanced oesophago-gastric cancer are likely to involve biologically relevant targets, which either alone or in combination with chemotherapy, may result in prolonged disease stabilisation or tumour response, hence improving patient outcomes (QOL, symptom control and survival). One such biological target is the epidermal growth factor receptor (EGFR). The role of EGFR in advanced oesophago-gastric cancer is unknown although high EGFR expression is known to occur in around 60-80% of patients and is associated with an adverse prognosis and resistance to chemotherapy. Furthermore, responses have been observed using agents targeting EGFR in advanced oesophago-gastric cancer. Cetuximab is a well-characterised, relatively non-toxic antibody directed against EGFR. Cetuximab has been used as a single agent and in combination with chemotherapy in a variety of cancers. Hence it seems appropriate to examine the role of cetuximab in advanced oesophago-gastric cancer. Considering the fact that docetaxel based regimens appear highly active in advanced oesophago-gastric cancer, there is a strong rationale for combining docetaxel with cetuximab. Synergy between taxanes and other agents targeting the family of EGFRs has been observed in other types of cancer. Therefore we have developed this Phase II study of cetuximab plus docetaxel in patients with advanced (recurrent or metastatic) oesophago-gastric cancer who are refractory to docetaxel therapy. This is an optional extension study for patients who have participated in ATTAX (AG0603) (all of whom receive docetaxel) and who have progressed either during or within 6 months of docetaxel based chemotherapy.