Phase 2
Completed N=72
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
Source: ClinicalTrials.gov NCT00215644 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Percentage of Participants With Objective Response Assessed by Independent Review Committee — 31; 58 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response Assessed by Independent Review Committee |
31; 58 | — |
| SECONDARY Duration of Objective Response Assessed by Independent Review Committee |
NA; NA | — |
| SECONDARY Progression-Free Survival |
4.8; 7.1 | — |
| SECONDARY Overall Survival (OS) |
9.4; 12.2 | — |
| SECONDARY 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 |
53.3; 67.9; 0.0; -10.0 | — |
| SECONDARY Protein Biomarkers Levels |
— | — |
| SECONDARY Percentage of Participants With Anti-Matuzumab Antibodies |
— | — |
| SECONDARY Matuzumab Serum Concentration |
— | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00215644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.