At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, adenocarcinoma of the gastroesophageal junction, or adenocarcinoma of the stomach
- ✓Metastatic disease
- ✓Measurable disease by diagnostic CT scan or MRI
- ✓Radiographic progression within 12 weeks from the last dose of prior cisplatin and irinotecan hydrochloride (given as adjuvant, neoadjuvant, or for metastatic disease)
- ✕Prior severe infusion reaction to a monoclonal antibody
- ✕History of allergic reactions to irinotecan hydrochloride, cisplatin, or other study agents
- ✕Prior intolerance to irinotecan hydrochloride or cisplatin despite dose reductions
- ✕Uncontrolled illness including active infection requiring parenteral antibiotics, symptomatic heart failure, unstable angina, uncontrolled hypertension, clinically significant cardiac arrhythmia, or myocardial infarction within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Cetuximab Plus Cisplatin and Irinotecan in Patients With Irinotecan and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer
In Brief
A Phase 2 clinical trial evaluating cetuximab, cisplatin, and 4 other interventions for Esophageal Cancer and Gastric Cancer. Completed, enrolled 16 participants across 1 site.
Detailed Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin and irinotecan may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin and irinotecan works in treating patients with metastatic esophageal cancer, gastroesophageal junction cancer, or gastric cancer that did not respond to previous irinotecan and cisplatin.