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 - EXPAND (Erbitux in combination with Xeloda

Conditions: advanced esophago-gastric cancer
MedDRA version: 9.1Level: LLTClassification code 10062878Term: Gastrooesophageal cancer

Registration Number: EUCTR2007-004219-75-IT

Lead Sponsor: Merck KGaA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 870

Inclusion Criteria

Written informed consent before any study-related activities are carried out Age ≥ 18 years Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (AEG types I-III according to Siewert classification) Archived tumor material sample for at least subsequent standardized EGFR expression assessment Investigators must make sure in advance that appropriate archived tumor material is available from a potentially eligible subject, and that a sample can be shipped to a central repository if the subject agrees to participate. Unresectable advanced (M0) or unresectable metastatic (M1) disease If unresectable advanced disease, at least one measurable locoregional lymph node or other measurable extraluminal tumor lesion ≥ 2cm (independent of whether measured by conventional techniques or spiral CT scan) must be documented. At least one radiographically documented measurable lesion in a previously non-irradiated area according to RECIST, i.e. this lesion must be adequately measurable in at least one dimension (longest diameter to be recorded) as ≥ 2cm by conventional techniques or ≥ 1 cm by spiral CT scan. Primary tumor site will be considered as a nonmeasurable lesion only. ECOG-performance status 0-1 Estimated life expectancy > 12 weeks Medically accepted contraception (if the risk of conception exists) GFR ≥ 60mL/min (Cockroft-Gault formula) ASAT ≤ 2.5 x ULN and ALAT ≤ 2.5 x ULN Bilirubin ≤ 3 x ULN ANC ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Hemoglobin ≥ 10 g/dL (without transfusions) Sodium and potassium within normal limits or ≤ 10% above or below (supplementation permitted)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior chemotherapy - however: Previous (neo-)adjuvant (radio-)chemotherapy allowed if finished > 1 year prior to start of study treatment and no more than 300 mg/m2 cisplatin has been administered Prior treatment with an antibody or molecule targeting EGFR- and/or VEGFR-related signaling pathways Brain metastasis and/or leptomeningeal disease (known or suspected) Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug in the 30 days before the start of study treatment Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol except for physiologic replacement Clinically relevant coronary artery disease (NYHA functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia Active hepatitis B or C Chronic diarrhea or short bowel syndrome Presence of any contraindication to treatment with cetuximab, capecitabine and cisplatin including: - Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs - Known dihydropyrimidine dehydrogenase (DPD) deficiency - Subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption - Current treatment with sorivudine or its chemically related analogues, such as brivudine - Symptomatic peripheral neuropathy NCI-CTC AE grade ≥ 2 and/or ototoxicity NCI-CTC AE grade ≥ 2, except if due to trauma or mechanical impairment due to tumor mass Pregnancy or lactation period Concurrent treatment with a non-permitted drug Treatment in another clinical study within the past 30 days Previous malignancy other than gastric cancer in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent Legal incapacity or limited legal capacity Significant disease which, in the investigator?s opinion, would exclude the subject from the study