Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
NCT ID: NCT00678535
Last Updated: 2014-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
904 participants
INTERVENTIONAL
2008-06-30
2013-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cetuximab plus Capecitabine plus Cisplatin
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.
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.
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.
Capecitabine plus Cisplatin
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Florian Lordick, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig Germany
Locations
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Research site
Rosario, , Argentina
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Coburg VIC, , Australia
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Frankston, VIC, , Australia
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Perth, , Australia
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Graz, , Austria
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Kufstein, , Austria
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Steyr, , Austria
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Vienna, , Austria
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Zams, , Austria
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Bonheiden, , Belgium
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Brussels, , Belgium
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Verviers, , Belgium
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Campinas, , Brazil
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Ijuí, , Brazil
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Jaú, , Brazil
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Porto Alegre, , Brazil
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Salvador, , Brazil
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Santo André, , Brazil
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Sâo Paulo, , Brazil
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Reñaca, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Valparaíso, , Chile
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Beijing, , China
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Guangzhou, , China
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Hefei, , China
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Nanjing, , China
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Shanghai, , China
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Shenyang, , China
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Besançon, , France
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Clermont-Ferrand, , France
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La Roche-sur-Yon, , France
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Marseille, , France
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Paris, , France
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Rennes, , France
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Berlin, , Germany
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Bielefeld, , Germany
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Braunschweig, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Frankfurt, , Germany
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Giessen, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Ludwigshafen, , Germany
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Mainz, , Germany
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München, , Germany
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Offenbach, , Germany
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Regensburg, , Germany
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Schwäbisch Hall, , Germany
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Schweinfurt, , Germany
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Stuttgart, , Germany
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Timisoara, , Germany
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Troisdorf, , Germany
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Ulm, , Germany
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Weiden, , Germany
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Weilheim, , Germany
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Ioannina, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Budapest, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Tatabánya, , Hungary
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Haifa, , Israel
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Jerusalem, , Israel
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Petach Tiqva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Ancona, , Italy
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Bologna, , Italy
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Milan, , Italy
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Napoli, , Italy
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Roma, , Italy
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Rozzano (Milano), , Italy
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Chiba, , Japan
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Ehime, , Japan
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Hokkaido, , Japan
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Kōtoku, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Saitama, , Japan
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Shizuoka, , Japan
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Tochigi, , Japan
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Tokyo, , Japan
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Yokohama, , Japan
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Gdansk, , Poland
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Lublin, , Poland
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Opole, , Poland
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Wroclaw, , Poland
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Sana Maria Da Feira, , Portugal
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Baia Mare, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Timișoara, , Romania
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Kazan', , Russia
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Moscow, , Russia
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Obninsk, , Russia
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Saint Petersburg, , Russia
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Anyang, , South Korea
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Daegu, , South Korea
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Inchon-si, , South Korea
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Seongnam, , South Korea
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Seoul, , South Korea
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Alicante, , Spain
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El Palmar-Murcia, , Spain
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Lugo, , Spain
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Pamplona, , Spain
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Santander, , Spain
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Seville, , Spain
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Valencia, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung County, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Guildford, , United Kingdom
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Manchester, , United Kingdom
Countries
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Other Identifiers
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2007-004219-75
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMR 200048-052
Identifier Type: -
Identifier Source: org_study_id
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