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Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075738 |
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.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus |
Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed esophageal cancer
At least 1 unidimensionally measurable metastatic lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
France | |
Centre Hospital Universitaire Hop Huriez | |
Lille, France, 59037 | |
Centre Jean Bernard | |
Le Mans, France, 72000 | |
Centre Medico-Chirurgical Foch | |
Suresnes, France, 92151 | |
Clinique Armoricaine De Radiologie | |
Saint Brieuc, France, F-22015 | |
Clinique Francois | |
Saint-Dizier, France, 52100 | |
Clinique La Casamance | |
Abugne, France, 13400 | |
Clinique Saint Jean | |
Lyon, France, 69008 | |
Hopital Tenon | |
Paris, France, 75970 | |
Hopital Bichat - Claude Bernard | |
Paris, France, 75018 | |
Hopital Drevon | |
Dijon, France, 21000 | |
Hopital Haut Leveque | |
Pessac, France, 33604 | |
Hopital Notre-Dame de Bon Secours | |
Metz, France, 57038 | |
Hopital Saint Andre | |
Bordeaux, France, 33075 | |
Hopital Saint Antoine | |
Paris, France, 75571 | |
Clinique Ste - Marie | |
Pontoise, France, 95300 |
Investigator: | Pascal Artru, MD | Clinique Saint Jean |
Study ID Numbers: | CDR0000349275, FRE-GERCOR-D00-2, EU-20328 |
Study First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075738 History of Changes |
Health Authority: | United States: Federal Government |
stage IV esophageal cancer recurrent esophageal cancer |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Esophageal Neoplasms Irinotecan Leucovorin Cisplatin Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex Esophageal Cancer Trace Elements |
Immunosuppressive Agents Recurrence Camptothecin Carcinoma Calcium, Dietary Digestive System Diseases Radiation-Sensitizing Agents Esophageal Disorder Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases Antineoplastic Agents, Phytogenic |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Irinotecan Physiological Effects of Drugs Leucovorin Neoplasms by Site Cisplatin Vitamins Therapeutic Uses Micronutrients |
Digestive System Neoplasms Vitamin B Complex Growth Substances Enzyme Inhibitors Immunosuppressive Agents Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Fluorouracil Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Antineoplastic Agents, Phytogenic |