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Stomach Neoplasms

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Immunoglobulins

EMD 72000 (matuzumab) + ECX

David Cunningham, Professor

The main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).

In addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).

Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer

A Phase I Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Three Doses of Humanised EGFR Antibody EMD 72000 in Combination With ECX in Patients With Advanced Oesophagogastric Adenocarcinoma

Merck KGaA, Darmstadt, Germany

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Anti-Infective Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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(mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.

Matuzumab

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.

Medical Responsible

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.

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

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

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.

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.

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.

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

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.

Only selected AEs were collected and reported.

Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m\^2, cisplatin 60 mg/m\^2 on Day 1 and capecitabine 1250 mg/m\^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day.

Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab

Participants received epirubicin 50 mg/m\^2, cisplatin 60 mg/m\^2 on Day 1 and capecitabine 1250 mg/m\^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn.

ECX Only

Total

Age, Continuous

Sex: Female, Male

Intent-to-Treat (ITT) population included all participants who received at least 1 cycle of matuzumab or any component of ECX.

Merck KGaA Communication Center,

Percentage of Participants With Objective Response Assessed by Independent Review Committee

Duration of Objective Response Assessed by Independent Review Committee

Progression-Free Survival

Overall Survival (OS)

Baseline

Post-Baseline

ITT population. Here, overall number of participants analyzed = participants who were evaluable for this outcome and "Number analyzed" = participants evaluable for specified timepoint for each arm, respectively.

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

Data for this outcome was not collected from any of the participant; hence, no data available for reporting.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer	NCT00113581	Esophageal Canc... Gastric Cancer	EMD 72000 (matu...	18 Years -	Merck KGaA, Darmstadt, Germany
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer	NCT00215644	Esophageal Canc... Gastric Cancer	Matuzumab Epirubicin Cisplatin Capecitabine	18 Years -	Merck KGaA, Darmstadt, Germany
Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer	NCT00113581	Esophageal Canc... Gastric Cancer	EMD 72000 (matu...	18 Years -	Merck KGaA, Darmstadt, Germany
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer	NCT00215644	Esophageal Canc... Gastric Cancer	Matuzumab Epirubicin Cisplatin Capecitabine	18 Years -	Merck KGaA, Darmstadt, Germany

Spots Global Cancer Trial Database for matuzumab

Every month we try and update this database with for matuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for matuzumab

Every month we try and update this database with for matuzumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for matuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.