Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer (MATRIX EG)

March 27, 2018 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Oldenburg, Germany
        • Research Site
      • Recklinghausen, Germany
        • Research Site
  • Spain
      • A Coruna, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Cadiz, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
  • Switzerland
      • Bern, Switzerland
        • Research Site
      • Geneva, Switzerland
        • Research Site
      • Lausanne, Switzerland
        • Research Site
      • St. Gallen, Switzerland
        • Research Site
  • United Kingdom
      • 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
        • Research Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
Drug: Matuzumab
Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
Other Names:
  • EMD 72000
Drug: Epirubicin
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.
Drug: Cisplatin
Participants will receive cisplatin 60 mg/m^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
Drug: Capecitabine
Participants will receive capecitabine 1250 mg/m^2 daily in a 21-day cycles up to a maximum of 8 cycles.
Active Comparator: ECX Only
Drug: Epirubicin
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.
Drug: Cisplatin
Participants will receive cisplatin 60 mg/m^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
Drug: Capecitabine
Participants will receive capecitabine 1250 mg/m^2 daily in a 21-day cycles up to a maximum of 8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response Assessed by Independent Review Committee
Time Frame: Baseline up to PD or death due to any cause (up to approximately 3 years)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Objective Response Assessed by Independent Review Committee
Time Frame: From first documented objective response to PD or death due to any cause (up to approximately 3 years)
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.
From first documented objective response to PD or death due to any cause (up to approximately 3 years)
Progression-Free Survival
Time Frame: Baseline up to PD or death due to any cause (up to approximately 3 years)
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.
Baseline up to PD or death due to any cause (up to approximately 3 years)
Overall Survival (OS)
Time Frame: Baseline until death due to any cause (up to approximately 3 years)
OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.
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
Time Frame: Baseline (Day 1), Post Baseline (Up to 3 Years)
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.
Baseline (Day 1), Post Baseline (Up to 3 Years)
Protein Biomarkers Levels
Time Frame: Baseline up to approximately 3 years
Baseline up to approximately 3 years
Percentage of Participants With Anti-Matuzumab Antibodies
Time Frame: Baseline up to approximately 3 years
Baseline up to approximately 3 years
Matuzumab Serum Concentration
Time Frame: Baseline up to approximately 3 years
Baseline up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2005

Primary Completion (Actual)

July 31, 2008

Study Completion (Actual)

August 31, 2008

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMD 72000-032
  • 2005-000146-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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