Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00678535




Registration number
NCT00678535
Ethics application status
Date submitted
13/05/2008
Date registered
15/05/2008
Date last updated
21/07/2014

Titles & IDs
Public title
Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
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
Secondary ID [1] 0 0
2007-004219-75
Secondary ID [2] 0 0
EMR 200048-052
Universal Trial Number (UTN)
Trial acronym
EXPAND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - Capecitabine
Treatment: Drugs - Cisplatin

Experimental: Cetuximab plus Capecitabine plus Cisplatin -

Active comparator: Capecitabine plus Cisplatin -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments
Timepoint [1] 0 0
Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)
Secondary outcome [2] 0 0
Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments
Timepoint [2] 0 0
Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)
Secondary outcome [3] 0 0
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [3] 0 0
Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Secondary outcome [4] 0 0
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Timepoint [4] 0 0
Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Secondary outcome [5] 0 0
Safety - Number of Participants With Adverse Events (AEs)
Timepoint [5] 0 0
Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)

Eligibility
Key inclusion criteria
* 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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/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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
904
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research site - Coburg VIC
Recruitment hospital [2] 0 0
Research site - Frankston, VIC
Recruitment hospital [3] 0 0
Research site - Perth
Recruitment postcode(s) [1] 0 0
- Coburg VIC
Recruitment postcode(s) [2] 0 0
- Frankston, VIC
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Rosario
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Kufstein
Country [4] 0 0
Austria
State/province [4] 0 0
Steyr
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Austria
State/province [6] 0 0
Zams
Country [7] 0 0
Belgium
State/province [7] 0 0
Bonheiden
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles
Country [9] 0 0
Belgium
State/province [9] 0 0
Verviers
Country [10] 0 0
Brazil
State/province [10] 0 0
Campinas
Country [11] 0 0
Brazil
State/province [11] 0 0
Ijui
Country [12] 0 0
Brazil
State/province [12] 0 0
Jaú
Country [13] 0 0
Brazil
State/province [13] 0 0
Porto Alegre
Country [14] 0 0
Brazil
State/province [14] 0 0
Salvador
Country [15] 0 0
Brazil
State/province [15] 0 0
Santo André
Country [16] 0 0
Brazil
State/province [16] 0 0
Sâo Paulo
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Pleven
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Plovdiv
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Rousse
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
Chile
State/province [21] 0 0
Reñaca
Country [22] 0 0
Chile
State/province [22] 0 0
Santiago
Country [23] 0 0
Chile
State/province [23] 0 0
Temuco
Country [24] 0 0
Chile
State/province [24] 0 0
Valparaiso
Country [25] 0 0
China
State/province [25] 0 0
Beijing
Country [26] 0 0
China
State/province [26] 0 0
Guangzhou
Country [27] 0 0
China
State/province [27] 0 0
Hefei
Country [28] 0 0
China
State/province [28] 0 0
Nanjing
Country [29] 0 0
China
State/province [29] 0 0
Shanghai
Country [30] 0 0
China
State/province [30] 0 0
Shenyang
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Brno
Country [32] 0 0
Czech Republic
State/province [32] 0 0
Hradec Králové
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Prague 5
Country [34] 0 0
France
State/province [34] 0 0
Besancon
Country [35] 0 0
France
State/province [35] 0 0
Clermont Ferrand Cedex 1
Country [36] 0 0
France
State/province [36] 0 0
La Roche sur Yon
Country [37] 0 0
France
State/province [37] 0 0
Marseille
Country [38] 0 0
France
State/province [38] 0 0
Paris 14
Country [39] 0 0
France
State/province [39] 0 0
Rennes
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Bielefeld
Country [42] 0 0
Germany
State/province [42] 0 0
Braunschweig
Country [43] 0 0
Germany
State/province [43] 0 0
Dresden
Country [44] 0 0
Germany
State/province [44] 0 0
Essen
Country [45] 0 0
Germany
State/province [45] 0 0
Esslingen
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt
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Germany
State/province [47] 0 0
Giessen
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Germany
State/province [48] 0 0
Hamburg
Country [49] 0 0
Germany
State/province [49] 0 0
Heidelberg
Country [50] 0 0
Germany
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Köln
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Germany
State/province [51] 0 0
Ludwigshafen
Country [52] 0 0
Germany
State/province [52] 0 0
Mainz
Country [53] 0 0
Germany
State/province [53] 0 0
München
Country [54] 0 0
Germany
State/province [54] 0 0
Offenbach
Country [55] 0 0
Germany
State/province [55] 0 0
Regensburg
Country [56] 0 0
Germany
State/province [56] 0 0
Schweinfurt
Country [57] 0 0
Germany
State/province [57] 0 0
Schwäbisch Hall
Country [58] 0 0
Germany
State/province [58] 0 0
Stuttgart
Country [59] 0 0
Germany
State/province [59] 0 0
Timisoara
Country [60] 0 0
Germany
State/province [60] 0 0
Troisdorf
Country [61] 0 0
Germany
State/province [61] 0 0
Ulm
Country [62] 0 0
Germany
State/province [62] 0 0
Weiden
Country [63] 0 0
Germany
State/province [63] 0 0
Weilheim
Country [64] 0 0
Greece
State/province [64] 0 0
Ioannina
Country [65] 0 0
Greece
State/province [65] 0 0
Thessaloniki
Country [66] 0 0
Hong Kong
State/province [66] 0 0
Hong Kong
Country [67] 0 0
Hungary
State/province [67] 0 0
Budapest
Country [68] 0 0
Hungary
State/province [68] 0 0
Gyor
Country [69] 0 0
Hungary
State/province [69] 0 0
Kaposvar
Country [70] 0 0
Hungary
State/province [70] 0 0
Tatabanya
Country [71] 0 0
Israel
State/province [71] 0 0
Haifa
Country [72] 0 0
Israel
State/province [72] 0 0
Jerusalem
Country [73] 0 0
Israel
State/province [73] 0 0
Petach Tiqva
Country [74] 0 0
Israel
State/province [74] 0 0
Ramat Gan
Country [75] 0 0
Israel
State/province [75] 0 0
Tel Aviv
Country [76] 0 0
Italy
State/province [76] 0 0
Ancona
Country [77] 0 0
Italy
State/province [77] 0 0
Bologna
Country [78] 0 0
Italy
State/province [78] 0 0
Milano
Country [79] 0 0
Italy
State/province [79] 0 0
Napoli
Country [80] 0 0
Italy
State/province [80] 0 0
Roma
Country [81] 0 0
Italy
State/province [81] 0 0
Rozzano (Milano)
Country [82] 0 0
Japan
State/province [82] 0 0
Chiba
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Japan
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Ehime
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Japan
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Hokkaido
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Japan
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Koto-ku
Country [86] 0 0
Japan
State/province [86] 0 0
Nagoya
Country [87] 0 0
Japan
State/province [87] 0 0
Osaka
Country [88] 0 0
Japan
State/province [88] 0 0
Saitama
Country [89] 0 0
Japan
State/province [89] 0 0
Shizuoka
Country [90] 0 0
Japan
State/province [90] 0 0
Tochigi
Country [91] 0 0
Japan
State/province [91] 0 0
Tokyo
Country [92] 0 0
Japan
State/province [92] 0 0
Yokohama
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Anyang
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Daegu
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Inchon-si
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Seongnam
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
Poland
State/province [98] 0 0
Gdansk
Country [99] 0 0
Poland
State/province [99] 0 0
Lublin
Country [100] 0 0
Poland
State/province [100] 0 0
Opole
Country [101] 0 0
Poland
State/province [101] 0 0
Wroclaw
Country [102] 0 0
Portugal
State/province [102] 0 0
Sana Maria da Feira
Country [103] 0 0
Romania
State/province [103] 0 0
Baia-Mare
Country [104] 0 0
Romania
State/province [104] 0 0
Bucharest
Country [105] 0 0
Romania
State/province [105] 0 0
Cluj-Napoca
Country [106] 0 0
Romania
State/province [106] 0 0
Iasi
Country [107] 0 0
Romania
State/province [107] 0 0
Timisoara
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Kazan
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Moscow
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Obninsk
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Saint-Petersburg
Country [112] 0 0
Spain
State/province [112] 0 0
Alicante
Country [113] 0 0
Spain
State/province [113] 0 0
El Palmar-Murcia
Country [114] 0 0
Spain
State/province [114] 0 0
Lugo
Country [115] 0 0
Spain
State/province [115] 0 0
Pamplona
Country [116] 0 0
Spain
State/province [116] 0 0
Santander
Country [117] 0 0
Spain
State/province [117] 0 0
Seville
Country [118] 0 0
Spain
State/province [118] 0 0
Valencia
Country [119] 0 0
Taiwan
State/province [119] 0 0
Changhua
Country [120] 0 0
Taiwan
State/province [120] 0 0
Kaohsiung County
Country [121] 0 0
Taiwan
State/province [121] 0 0
Kaohsiung
Country [122] 0 0
Taiwan
State/province [122] 0 0
Taichung City
Country [123] 0 0
Taiwan
State/province [123] 0 0
Tainan
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taipei
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taoyuan
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Guildford
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck KGaA, Darmstadt, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Florian Lordick, MD, PhD
Address 0 0
University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00678535