At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
- ✓Metastatic disease
- ✓EGFR expression documented by immunohistology from archived tissue
- ✓ECOG performance status 0-1
- ✕Prior chemotherapy within 12 months (unless neo-adjuvant or adjuvant)
- ✕Radiotherapy or major surgery within 4 weeks prior to treatment
- ✕Brain metastases
- ✕Peripheral neuropathy or ototoxicity Grade ≥2 (NCICTC V3)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Matuzumab, Epirubicin, and 2 other interventions for Esophageal Cancer and Gastric Cancer. Completed, enrolled 72 participants across 22 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
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.