Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00075738
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Clinical benefit Tolerability Local relapse-free survival Overall survival
Trial Locations
- Locations (15)
Clinique La Casamance
🇫🇷Abugne, France
Hopital Drevon
🇫🇷Dijon, France
Centre Jean Bernard
🇫🇷Le Mans, France
Clinique Saint Jean
🇫🇷Lyon, France
Hopital Saint Antoine
🇫🇷Paris, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Centre Hospital Universitaire Hop Huriez
🇫🇷Lille, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Hopital Tenon
🇫🇷Paris, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Hopital Haut Leveque
🇫🇷Pessac, France
Clinique Ste - Marie
🇫🇷Pontoise, France
Clinique Francois
🇫🇷Saint-Dizier, France
Centre Medico-Chirurgical Foch
🇫🇷Suresnes, France