Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
- Conditions
- Esophageal CancerGastric Cancer
- Interventions
- Registration Number
- NCT00215644
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab Epirubicin - Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab Cisplatin - ECX Only Cisplatin - Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab Capecitabine - ECX Only Epirubicin - ECX Only Capecitabine - Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab Matuzumab -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Objective Response Assessed by Independent Review Committee 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
Name Time Method Duration of Objective Response Assessed by Independent Review Committee 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.
Protein Biomarkers Levels Baseline up to approximately 3 years Percentage of Participants With Anti-Matuzumab Antibodies Baseline up to approximately 3 years Matuzumab Serum Concentration Baseline up to approximately 3 years Progression-Free Survival 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.
Overall Survival (OS) 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.
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 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.
Trial Locations
- Locations (1)
Research Site
🇬🇧Portsmouth, United Kingdom