Phase II Trial of Cetuximab Plus Cisplatin and Irinotecan in Patients With Irinotecan and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer
- Determine the response rate in patients with irinotecan hydrochloride- and
cisplatin-refractory metastatic esophageal, gastroesophageal junction, or gastric
cancer treated with cetuximab, cisplatin, and irinotecan hydrochloride.
- Determine the median survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
- Determine the adverse event profiles in patients treated with this regimen.
- Assess epidermal growth factor receptor expression in tumor tissue from patients
treated with this regimen.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and cisplatin IV over
30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8. Treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor biopsy at baseline to evaluate epidermal growth factor receptor by
After completion of study treatment, patients are followed every 3 months for up to 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete and partial response rate
David H. Ilson, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|