At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed unresectable or metastatic stage IV esophageal or gastric adenocarcinoma
- ✓Squamous cell carcinoma and mixed squamous/adenomatous histology are excluded; adenocarcinoma only
- ✓Measurable disease ≥1 cm by spiral CT or ≥2 cm by other imaging per RECIST criteria
- ✓Must have EGFR tissue available: at least one paraffin block or twenty unstained slides
- ✕Prior cetuximab or other EGFR pathway-targeted therapy (bevacizumab is permitted)
- ✕Prior severe infusion reaction to monoclonal antibody
- ✕Any chemotherapy or radiation within 28 days prior to study entry
- ✕Major surgery within 4 weeks or minor surgery within 2 weeks of first cetuximab infusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Cetuximab in Unresectable or Metastatic Esophageal and Gastric Carcinoma
In Brief
A Phase 2 clinical trial evaluating Cetuximab for Esophageal Cancer and 2 related conditions. Completed, enrolled 43 participants across 4 sites.
Detailed Summary
Purpose: There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased EGFR expression in a significant proportion of both esophageal and gastric carcinomas. Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted in inhibition of tumor growth. Agents designed to block the EGFR pathway have demonstrated disease control among previously treated patients with metastatic esophageal and gastric cancer. The proposed mechanism of action for cetuximab is its ability to effectively disrupt EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle progression, induces apoptosis, and also inhibits processes important for tumor growth, such as cell invasion and angiogenesis.