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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck KGaA

ClinicalTrials.gov Identifier:

NCT00678535

First received: May 13, 2008

Last updated: March 30, 2013

Last verified: March 2013

History of Changes

Results First Received: March 30, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Gastric Cancer
Interventions:	Drug: Cetuximab Drug: Capecitabine Drug: Cisplatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First/last participant (informed consent): June 2008/December 2010. Clinical data cut-off: 31 March 2012 Study completion 17 February 2013.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled: 1,191 screened for eligibility; 287 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 904 participants randomized.

Reporting Groups

	Description
Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Participant Flow: Overall Study

	Cetuximab Plus Capecitabine Plus Cisplatin	Capecitabine Plus Cisplatin
STARTED	455 ^[1]	449 ^[1]
COMPLETED	362 ^[2]	351 ^[2]
NOT COMPLETED	93	98

[1]	ITT population
[2]	subjects who died before or at 31 March 2012

Baseline Characteristics

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Reporting Groups

	Description
Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
Total	Total of all reporting groups

Baseline Measures

	Cetuximab Plus Capecitabine Plus Cisplatin	Capecitabine Plus Cisplatin	Total
Number of Participants [units: participants]	455	449	904
Age [units: years] Mean ± Standard Deviation	58.0 ± 11.16	58.5 ± 10.83	58.3 ± 11.00
Gender [units: participants]
Female	116	115	231
Male	339	334	673

Outcome Measures

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1. Primary:

Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments [ Time Frame: 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) ]

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2. Secondary:

Overall Survival (OS) [ Time Frame: 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) ]

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3. Secondary:

Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments [ Time Frame: Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012) ]

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4. Secondary:

Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: 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) ]

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5. Secondary:

Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire [ Time Frame: 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) ]

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6. Secondary:

Safety - Number of Participants With Adverse Events (AEs) [ Time Frame: 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) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merck.de

No publications provided

Responsible Party:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT00678535 History of Changes
Other Study ID Numbers:	EMR 200048-052, 2007-004219-75
Study First Received:	May 13, 2008
Results First Received:	March 30, 2013
Last Updated:	March 30, 2013
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Austria: Austrian Medicines and Medical Devices Agency Austria: Ethikkommission Belgium: Directorate general for the protection of Public health: Medicines Belgium: Ethics Committee Brazil: National Committee of Ethics in Research Bulgaria: Bulgarian Drug Agency Bulgaria: Ethics committee Chile: Comité de Ética Científico Chile: Comisión Nacional de Investigación Científica y Tecnológica China: Food and Drug Administration China: Ethics Committee Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: L’Agence nationale de sécurité du médicament et des produits de santé Germany: Paul-Ehrlich-Institut Greece: Ethics Committee Greece: National Organization of Medicines Hong Kong: Ethics Committee Israel: Ethics Commission Israel: Israeli Health Ministry Pharmaceutical Administration Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: Ethics Committee Japan: Foundation for Biomedical Research and Innovation Japan: Institutional Review Board Korea: Food and Drug Administration Korea: Institutional Review Board Poland: Ministry of Science and Higher Education Poland: National Institute of Medicines Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: Ethics Committee for Clinical Research Portugal: Health Ethic Committee Portugal: National Pharmacy and Medicines Institute Romania: Ethics Committee Romania: Ministry of Public Health Romania: National Agency for Medicines and Medical Devices Romania: National Authority for Scientific Research Russia: Ethics Committee Russia: Pharmacological Committee, Ministry of Health Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica Taiwan : Food and Drug Administration Taiwan: Institutional Review Board United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Councils UK

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