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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Clinique La Casamance
Abugne, France
Hopital Saint Andre
Bordeaux, France
Hopital Drevon
Dijon, France
Objective response rate
Clinical benefit
Tolerability
Local relapse-free survival
Overall survival
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Jean Bernard
Le Mans, France
Centre Hospital Universitaire Hop Huriez
Lille, France
Clinique Saint Jean
Lyon, France
Hopital Notre-Dame de Bon Secours
Metz, France
Hopital Bichat - Claude Bernard
Paris, France
Hopital Saint Antoine
Paris, France
Hopital Tenon
Paris, France
...and 5 more locations