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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-GERCOR-D00-2 | |||
| EU-20328 |
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| fluorouracil | Drug | |||
| irinotecan hydrochloride | Drug | |||
| leucovorin calcium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit | ||
| Tolerability | ||
| Local relapse-free survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed esophageal cancer
At least 1 unidimensionally measurable metastatic lesion
No known symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Artru, MD | Clinique Saint Jean |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique La Casamance | Abugne | 13400 | France | |||
| Hopital Saint Andre |
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| Overall survival |
| Bordeaux |
| 33075 |
| France |
| Hopital Drevon | Dijon | 21000 | France |
| Centre Jean Bernard | Le Mans | 72000 | France |
| Centre Hospital Universitaire Hop Huriez | Lille | 59037 | France |
| Clinique Saint Jean | Lyon | 69008 | France |
| Hopital Notre-Dame de Bon Secours | Metz | 57038 | France |
| Hopital Bichat - Claude Bernard | Paris | 75018 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| Hopital Tenon | Paris | 75970 | France |
| Hopital Haut Leveque | Pessac | 33604 | France |
| Clinique Ste - Marie | Pontoise | 95300 | France |
| Clinique Armoricaine De Radiologie | Saint-Brieuc | F-22015 | France |
| Clinique Francois | Saint-Dizier | 52100 | France |
| Centre Medico-Chirurgical Foch | Suresnes | 92151 | France |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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