Status:
COMPLETED
Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 rele...
Eligibility Criteria
Inclusion
- 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
- Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9 per liter
- Platelets \>= 100 \* 10\^9 per liter
- Hemoglobin \>=10 gram per deciliter (g/dL) (without transfusions)
- Sodium and potassium within normal limits or =\< 10 percent above or below (supplementation permitted)
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
904 Patients enrolled
Trial Details
Trial ID
NCT00678535
Start Date
June 1 2008
End Date
February 1 2013
Last Update
July 21 2014
Active Locations (130)
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1
Research site
Rosario, Argentina
2
Research site
Coburg VIC, Australia
3
Research site
Frankston, VIC, Australia
4
Research site
Perth, Australia