Resumen

The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) \[XP\] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9 per liter
Platelets \>= 100 \* 10\^9 per liter
Written informed consent before any study-related activities are carried out
Age greater than or equal to (\>=) 18 years
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Adenocarcinoma of the gastroesophageal junction \[AEG\] Types I-III according to Siewert classification)
Archived tumor material sample for at least subsequent standardized Epidermal Growth Factor Receptor (EGFR) expression assessment
Unresectable advanced (M0) or unresectable metastatic (M1) disease
At least one radiographically documented measurable lesion in a previously non-irradiated area according to response evaluation criteria in solid tumors (RECIST). The primary tumor site is to be considered as a non-measurable lesion only
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Estimated life expectancy greater than (\>) 12 weeks
Medically accepted contraception (if the risk of conception exists)
Glomerular filtration rate (GFR) \>= 60 milliliter per minute (mL/min) The GFR is based on the Cockcroft-Gault formula for creatinine clearance
Aspartate-aminotransferase (ASAT) less than or equal to (=\<) 2.5 \* upper limit of normal (ULN) and alanine-aminotransferase (ALAT) =\< 2.5 \*ULN
Bilirubin =\< 3 \* ULN
Hemoglobin \>=10 gram per deciliter (g/dL) (without transfusions)
Sodium and potassium within normal limits or =\< 10 percent above or below (supplementation permitted)

Criterios de exclusión

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/m\^2 cisplatin has been administered
Prior treatment with an antibody or molecule targeting EGFR and/or Vascular Endothelial Growth Factor Receptor (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 within 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 (New York Heart Association \[NYHA\] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the 12 months before study Screening, or high risk of uncontrolled arrhythmia
Active Hepatitis B or C
Chronic diarrhea or short bowel syndrome
Presence of any contra-indication 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
Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Current treatment with sorivudine or chemically related analogues, such as brivudine
Symptomatic peripheral neuropathy National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade \>= 2 and/or ototoxicity NCI CTCAE 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 30 days prior to study screening
Previous malignancy other than gastric cancer within 5 years prior to study screening, except for basal cell cancer of the skin or pre-invasive 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

Intervenciones

drug

Cetuximab

Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m\^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.

drug

Capecitabine

Capecitabine 1000 mg/m\^2 will be administered orally twice daily from evening of Day 1 to morning of Day 15 for every 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.

drug

Cisplatin

Cisplatin 80 mg/m\^2 will be administered intravenously with infusion over 1 to 4 hours on Day 1 of each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Cetuximab

Capecitabine

Cisplatin

Ubicaciones

Research site

Patrocinadores