Esophageal Cancer Clinical Trial
Official title:
Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and
cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or
die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy as
first-line therapy works in treating patients with metastatic esophageal cancer.
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic esophageal cancer
treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line
therapy.
Secondary
- 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
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