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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-GERCOR-EPITAXD00-1 | |||
| EU-20326 |
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | |||
| epirubicin hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate | ||
| Time to tumor progression |
| Measure | Description | Time Frame |
|---|---|---|
| Survival without local relapse | ||
| Overall survival | ||
| Tolerability |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the stomach
Measurable disease
No known symptomatic brain metastases
No bone 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 |
|---|---|---|
| Christophe Louvet, MD, PhD | Hopital Saint Antoine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49036 | France | |||
| Centre Hospitalier Victor Dupouy |
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| Argenteuil |
| 95107 |
| France |
| Centre Hospital General Robert Ballanger | Aulnay-sous-Bois | 93602 | France |
| C.H.G. Beauvais | Beauvais | 60021 | France |
| Clinique Tivoli | Bordeaux | F-33000 | France |
| Hopital Louis Pasteur | Chartres | 28018 | France |
| Hopital Drevon | Dijon | 21000 | France |
| Clinique Sainte-Marguerite | Hyères | 83400 | France |
| Clinique Victor Hugo | Le Mans | F-72000 | France |
| Centre Hospital Universitaire Hop Huriez | Lille | 59037 | France |
| Clinique Saint Jean | Lyon | 69008 | France |
| Hopital de la Croix Rousse | Lyon | 69317 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Intercommunal Hospital | Montfermeil | 93370 | France |
| American Hospital of Paris | Neuilly-sur-Seine | F-92202 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| Hopital Saint Joseph | Paris | 75674 | France |
| Hopital Tenon | Paris | 75970 | France |
| Maison Medicale Marzet | Pau | 64000 | France |
| Hopital Rene Dubos | Pontoise | 95300 | France |
| C.H. Senlis | Senlis | 60309 | France |
| Hopital d'Instruction des Armes Sainte-Anne | Toulon | 83800 | France |
| CHRU de Tours - Hopital Trousseau | Tours | 37044 | France |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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