Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
MATRIX EG
Randomized Phase II Open-Label Controlled Study of EMD 72000 (Matuzumab), in Combination With the Chemotherapy Regimen ECX or the Chemotherapy Regimen ECX Alone as First-line Treatment in Subjects With Metastatic Esophago-Gastric Adenocarcinoma
2 other identifiers
interventional
72
4 countries
22
Brief Summary
The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2005
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2005
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2008
CompletedResults Posted
Study results publicly available
November 2, 2018
CompletedNovember 2, 2018
March 1, 2018
2.9 years
September 15, 2005
August 24, 2017
March 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Objective Response Assessed by Independent Review Committee
Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (\>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.
Baseline up to PD or death due to any cause (up to approximately 3 years)
Secondary Outcomes (7)
Duration of Objective Response Assessed by Independent Review Committee
From first documented objective response to PD or death due to any cause (up to approximately 3 years)
Progression-Free Survival
Baseline up to PD or death due to any cause (up to approximately 3 years)
Overall Survival (OS)
Baseline until death due to any cause (up to approximately 3 years)
Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score
Baseline (Day 1), Post Baseline (Up to 3 Years)
Protein Biomarkers Levels
Baseline up to approximately 3 years
- +2 more secondary outcomes
Study Arms (2)
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
EXPERIMENTALECX Only
ACTIVE COMPARATORInterventions
Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
Participants will receive epirubicin 50 milligrams per square meter (mg/m\^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles.
Participants will receive cisplatin 60 mg/m\^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
Participants will receive capecitabine 1250 mg/m\^2 daily in a 21-day cycles up to a maximum of 8 cycles.
Eligibility Criteria
You may qualify if:
- Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
- Metastatic disease
- Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from archived tissues
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- At least 1 measurable lesion (modified World Health Organization criteria)
You may not qualify if:
- Previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed greater than (\>) 12 months prior to study treatment
- Radiotherapy or major surgery within 4 weeks prior to treatment
- Brain metastases
- Peripheral neuropathy or ototoxicity greater than or equal to (\>/=) Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events Version 3 \[NCICTC V3\])
- Abnormal electrocardiogram (ECG)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Research Site
Essen, Germany
Research Site
Hamburg, Germany
Research Site
Oldenburg, Germany
Research Site
Recklinghausen, Germany
Research Site
A Coruña, Spain
Research Site
Barcelona, Spain
Research Site
Cadiz, Spain
Research Site
Valencia, Spain
Research Site
Bern, Switzerland
Research Site
Geneva, Switzerland
Research Site
Lausanne, Switzerland
Research Site
Sankt Gallen, Switzerland
Research Site
Northwood, Middlesex, United Kingdom
Research Site
Bournemouth, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Chelmsford, United Kingdom
Research Site
Guildford, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Newcastle, United Kingdom
Research Site
Northwood, United Kingdom
Research Site
Portsmouth, United Kingdom
Related Publications (1)
Rao S, Starling N, Cunningham D, Sumpter K, Gilligan D, Ruhstaller T, Valladares-Ayerbes M, Wilke H, Archer C, Kurek R, Beadman C, Oates J. Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) compared with epirubicin, cisplatin and capecitabine alone as first-line treatment in patients with advanced oesophago-gastric cancer: a randomised, multicentre open-label phase II study. Ann Oncol. 2010 Nov;21(11):2213-2219. doi: 10.1093/annonc/mdq247. Epub 2010 May 23.
PMID: 20497967RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merck KGaA Communication Center,
- Organization
- Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 22, 2005
Study Start
August 31, 2005
Primary Completion
July 31, 2008
Study Completion
August 31, 2008
Last Updated
November 2, 2018
Results First Posted
November 2, 2018
Record last verified: 2018-03