EXPAND (Erbitux in combination with Xeloda and cisplatine in advanced esophago-gastric cancer);Open-label, randomized, controlled, multicenter phase III study investigating cetuximab in combination with capecitabine (Xeloda, X) and cisplatin (P) versus XP alone as first-line treatment for subjects with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.

Please see for background information the protocol section 3, page 18.

Cetuximab in combination with chemotherapy as a 1st-line treatment of advanced
gastric
cancer showed promising response rates and encouraging survival data in 3 phase
II
studies (see section 3.3) [13, 14, 15]. In the present study, cetuximab will be
added to the
XP chemotherapy regimen (oral 5-FU prodrug capecitabine = Xeloda + cisplatin) to
demonstrate that addition of cetuximab provides a clinically relevant benefit
in this disease
setting.
XP is one of the current standard regimens for 1st-line treatment of advanced
gastric cancer [1]. The European Commission has recently approved the XP
regimen for
1st-line treatment of advanced gastric cancer. The XP combination regimen has
also gained
approval in other countries.

To demonstrate superiority of XP chemotherapy regimen plus cetuximab versus XP
alone as
first-line treatment for advanced gastric cancer in terms of PFS.

To assess cetuximab + XP versus XP alone with respect to: OS; overall response;
QoL; safety.

Multicenter open-label, randomized, controlled, phase III study. Subjects will
be randomized on a 1:1 basis to the following treatment: Group A: Cetuximab q
week + XP q 3 weeks, Group B: XP q 3 weeks.

Subjects will be randomized on a 1:1 basis to the following treatment: Group A:
Cetuximab q week + XP q 3 weeks, Group B: XP q 3 weeks.

Cetuximab: 400 mg/m2 at the first infusion, 250 mg/m2 every week as subsequent
infusions, i.v.

XP regimen as 3-week cycles: Capecitabine (Xeloda) 1000 mg/m2 twice daily from
evening of D1 until morning of D15, p.o. + cisplatin 80 mg/m2 on D1, i.v.

At the start of each cycle, the subject will be admitted to the hospital with
an overnight stay and will receive intravenous treatment of 4 hours. The
schedule of all assessments is described in the protocol section7, table 7.7.
Clinically relevant Adverse Events related to cetuximab are described in the
protocol, section 3.4.7.