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

Merck KGaA, Darmstadt, Germany72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Cancer Gastric Cancer

Interventions

MatuzumabDRUG

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(mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (22)

Research Site

Essen, Germany

Research Site

Hamburg, Germany

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

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.

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

Overall Survival (OS)

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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.

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