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

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ClinicalTrials.gov Identifier: NCT00215644
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: Matuzumab Drug: Epirubicin Drug: Cisplatin Drug: Capecitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2005
Actual Primary Completion Date : July 31, 2008
Actual Study Completion Date : August 31, 2008


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(mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Protein Biomarkers Levels [ Time Frame: Baseline up to approximately 3 years ]
  6. Percentage of Participants With Anti-Matuzumab Antibodies [ Time Frame: Baseline up to approximately 3 years ]
  7. Matuzumab Serum Concentration [ Time Frame: Baseline up to approximately 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215644


Locations
Germany
Research Site
Essen, Germany
Research Site
Hamburg, Germany
Research Site
Oldenburg, Germany
Research Site
Recklinghausen, Germany
Spain
Research Site
A Coruna, Spain
Research Site
Barcelona, Spain
Research Site
Cadiz, Spain
Research Site
Valencia, Spain
Switzerland
Research Site
Bern, Switzerland
Research Site
Geneva, Switzerland
Research Site
Lausanne, Switzerland
Research Site
St. Gallen, Switzerland
United Kingdom
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
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible Merck KGaA

Publications of Results:
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00215644     History of Changes
Other Study ID Numbers: EMD 72000-032
2005-000146-36 ( EudraCT Number )
First Posted: September 22, 2005    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: March 2018

Keywords provided by Merck KGaA:
Esophagus
Gastric
Adenocarcinoma
EGFR
matuzumab
EMD 72000
randomized
Epirubicin
cisplatin
capecitabine
Metastatic Esophago-Gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Cisplatin
Capecitabine
Epirubicin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors