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Esophageal CancerPhase 2MATRIX EGNCT00215644

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

A Phase 2 study testing Matuzumab, Epirubicin and Cisplatin in people with Esophageal Cancer and Gastric Cancer, run by Merck KGaA, Darmstadt, Germany at 22 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
Matuzumab, Epirubicin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
22 sitesin 4 countries
Study dates
31 Aug 2005to 31 Aug 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

22 sites in 4 countries.

22 sites in 4 countries

United Kingdom10 sites

  • Research Site

    Bournemouth

  • Research Site

    Cambridge

  • Research Site

    Chelmsford

  • Research Site

    Guildford

  • Research Site

    Leicester

  • Research Site

    London

  • Research Site

    Newcastle

  • Research Site

    Northwood, Middlesex

  • Research Site

    Northwood

  • Research Site

    Portsmouth

Other trials in United Kingdom

Germany4 sites

  • Research Site

    Essen

  • Research Site

    Hamburg

  • Research Site

    Oldenburg

  • Research Site

    Recklinghausen

Other trials in Germany

Spain4 sites

  • Research Site

    A Coruña

  • Research Site

    Barcelona

  • Research Site

    Cadiz

  • Research Site

    Valencia

Other trials in Spain

Switzerland4 sites

  • Research Site

    Bern

  • Research Site

    Geneva

  • Research Site

    Lausanne

  • Research Site

    Sankt Gallen

Other trials in Switzerland

About this study

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

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.

Being tested
Matuzumab, Epirubicin, Cisplatin, Capecitabine
Keywords
Esophagus, Gastric, Adenocarcinoma, EGFR, matuzumab, EMD 72000, randomized, Epirubicin, cisplatin, capecitabine, Metastatic Esophago-Gastric cancer
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MatuzumabDrug

    Also called EMD 72000

    Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.

  • EpirubicinDrug

    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.

  • CisplatinDrug

    Participants will receive cisplatin 60 mg/m^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.

  • CapecitabineDrug

    Participants will receive capecitabine 1250 mg/m^2 daily in a 21-day cycles up to a maximum of 8 cycles.

Study groups in NCT00215644
Study groupRoleWhat they receive
Epirubicin, Cisplatin, Capecitabine (ECX)+MatuzumabExperimentalNot described
Receives: Drug: Matuzumab; Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine
ECX OnlyActive comparatorNot described
Receives: Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to PD or death due to any cause (up to approximately 3 years)

Secondary outcomes (7)

  1. 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.

    Measured: From first documented objective response to PD or death due to any cause (up to approximately 3 years)

  2. 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.

    Measured: Baseline up to PD or death due to any cause (up to approximately 3 years)

  3. Overall Survival (OS)

    OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.

    Measured: Baseline until death due to any cause (up to approximately 3 years)

  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

    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.

    Measured: Baseline (Day 1), Post Baseline (Up to 3 Years)

  5. Protein Biomarkers Levels

    Measured: Baseline up to approximately 3 years

  6. Percentage of Participants With Anti-Matuzumab Antibodies

    Measured: Baseline up to approximately 3 years

  7. Matuzumab Serum Concentration

    Measured: Baseline up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study start31 Aug 2005
  3. Primary completion31 Jul 2008
  4. Study completion31 Aug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00215644
Sponsor's protocol ID
EMD 72000-032
Other IDs
2005-000146-36, 2005
Acronym
MATRIX EG
Status last verified
Mar 2018
First submitted
15 Sep 2005
Last updated
2 Nov 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 20497967

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Matuzumab, Epirubicin and Cisplatin in people with Esophageal Cancer and Gastric Cancer, run by Merck KGaA, Darmstadt, Germany at 22 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United Kingdom, Germany, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00215644, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.

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