Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
Recruitment status was Active, not recruiting
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.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus|
- Objective response rate [ Designated as safety issue: No ]
- Clinical benefit [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Local relapse-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
- Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075738
|Clinique La Casamance|
|Abugne, France, 13400|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Dijon, France, 21000|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|Centre Hospital Universitaire Hop Huriez|
|Lille, France, 59037|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Hopital Notre-Dame de Bon Secours|
|Metz, France, 57038|
|Paris, France, 75970|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Hopital Haut Leveque|
|Pessac, France, 33604|
|Clinique Ste - Marie|
|Pontoise, France, 95300|
|Clinique Armoricaine De Radiologie|
|Saint Brieuc, France, F-22015|
|Saint-Dizier, France, 52100|
|Centre Medico-Chirurgical Foch|
|Suresnes, France, 92151|
|Investigator:||Pascal Artru, MD||Clinique Saint Jean|