Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
- Determine the objective response rate in patients with metastatic esophageal cancer
treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line
- Determine the clinical benefit in patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
- Determine local relapse-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day
1. Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30
minutes on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence
of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 1 year.
Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Pascal Artru, MD
Clinique Saint Jean
United States: Federal Government