Back to resultsMatuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer (MATRIX EG)
Primary Purpose
Esophageal Cancer, Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Matuzumab
Epirubicin
Cisplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophagus, Gastric, Adenocarcinoma, EGFR, matuzumab, EMD 72000, randomized, Epirubicin, cisplatin, capecitabine, Metastatic Esophago-Gastric cancer
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
ECX Only
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of Objective Response Assessed by Independent Review Committee
Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: >25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.
Progression-Free Survival
PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.
Overall Survival (OS)
OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.
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
EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported.
Protein Biomarkers Levels
Percentage of Participants With Anti-Matuzumab Antibodies
Matuzumab Serum Concentration
Full Information
NCT ID
NCT00215644
First Posted
September 15, 2005
Last Updated
March 27, 2018
Sponsor
Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00215644
Brief Title
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
Acronym
MATRIX EG
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 31, 2005 (Actual)
Primary Completion Date
July 31, 2008 (Actual)
Study Completion Date
August 31, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
Esophagus, Gastric, Adenocarcinoma, EGFR, matuzumab, EMD 72000, randomized, Epirubicin, cisplatin, capecitabine, Metastatic Esophago-Gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
Arm Type
Experimental
Arm Title
ECX Only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Matuzumab
Other Intervention Name(s)
EMD 72000
Intervention Description
Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Participants will receive cisplatin 60 mg/m^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Participants will receive capecitabine 1250 mg/m^2 daily in a 21-day cycles up to a maximum of 8 cycles.
Primary Outcome Measure Information:
Title
Percentage of Participants With Objective Response Assessed by Independent Review Committee
Description
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.
Time Frame
Baseline up to PD or death due to any cause (up to approximately 3 years)
Secondary Outcome Measure Information:
Title
Duration of Objective Response Assessed by Independent Review Committee
Description
Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: >25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.
Time Frame
From first documented objective response to PD or death due to any cause (up to approximately 3 years)
Title
Progression-Free Survival
Description
PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.
Time Frame
Baseline up to PD or death due to any cause (up to approximately 3 years)
Title
Overall Survival (OS)
Description
OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.
Time Frame
Baseline until death due to any cause (up to approximately 3 years)
Title
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
Description
EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported.
Time Frame
Baseline (Day 1), Post Baseline (Up to 3 Years)
Title
Protein Biomarkers Levels
Time Frame
Baseline up to approximately 3 years
Title
Percentage of Participants With Anti-Matuzumab Antibodies
Time Frame
Baseline up to approximately 3 years
Title
Matuzumab Serum Concentration
Time Frame
Baseline up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Oldenburg
Country
Germany
Facility Name
Research Site
City
Recklinghausen
Country
Germany
Facility Name
Research Site
City
A Coruna
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Cadiz
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Bern
Country
Switzerland
Facility Name
Research Site
City
Geneva
Country
Switzerland
Facility Name
Research Site
City
Lausanne
Country
Switzerland
Facility Name
Research Site
City
St. Gallen
Country
Switzerland
Facility Name
Research Site
City
Northwood
State/Province
Middlesex
Country
United Kingdom
Facility Name
Research Site
City
Bournemouth
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
Country
United Kingdom
Facility Name
Research Site
City
Chelmsford
Country
United Kingdom
Facility Name
Research Site
City
Guildford
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Newcastle
Country
United Kingdom
Facility Name
Research Site
City
Northwood
Country
United Kingdom
Facility Name
Research Site
City
Portsmouth
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20497967
Citation
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.
Results Reference
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Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
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