Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00678535
• Date of registration: 13/05/2008
• Primary sponsor: Merck KGaA
• Public title: Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer EXPAND
• Scientific title: 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
• Date of first enrolment: June 2008
• Target sample size: 904
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00678535
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Austria, Belgium, Czech Republic, Germany, Hungary, Korea, Democratic People's Republic of, Korea, Republic of, Romania, Spain, Taiwan

Contacts

• Name: Florian Lordick, MD, PhD
• Affiliation: Medizische Klinik III Hamatologie und Onkologie Klinikum Braunschweig, Braunschweig, Germany

Key inclusion & exclusion criteria

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

- At least one radiographically documented measurable lesion in a previously
non-irradiated area according to RECIST

- ECOG performance status 0-1

- Estimated life expectancy > 12 weeks

- Medically accepted contraception (if the risk of conception exists)

- Glomerular filtration rate = 60mL/min

- ASAT = 2.5 x ULN and ALAT = 2.5 x ULN

- Bilirubin = 3 x ULN

- ANC = 1.5 x 10 to the power of 9/L

- Platelets = 100 x 10 to the power of 9/L

- Hemoglobin = 10 g/dL (without transfusions)

- Sodium and potassium within normal limits or = 10% above or below (supplementation
permitted)

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Gastric Cancer

Intervention(s)

Drug: Capecitabine and Cisplatin

Drug: Cetuximab + Capecitabine and Cisplatin

Primary Outcome(s)

Progression Free Survival [Time Frame: Various Timepoints]

Secondary Outcome(s)

Overall Response [Time Frame: Various Timepoints]

Overall Survival [Time Frame: Various Timepoints]

Quality of Life [Time Frame: Various Timepoints]

Safety [Time Frame: Various Timepoints]

Secondary ID(s)

EMR 200048-052

Source(s) of Monetary Support

Please refer to primary and secondary sponsors