Clinical trial · Interventional
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
NCT00215644CI-TRIAL-00035599MATRIX EGcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Matuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
- interventionNames
- Drug: Matuzumab
- Drug: Epirubicin
- Drug: Cisplatin
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- ECX Only
- interventionNames
- Drug: Epirubicin
- Drug: Cisplatin
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Percentage of Participants With Objective Response Assessed by Independent Review Committee
- timeFrame
- Baseline up to PD or death due to any cause (up to approximately 3 years)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTRao 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. PMID 20497967