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Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075465 |
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.
Condition | Intervention | Phase |
Gastric Cancer |
Drug: docetaxel Drug: epirubicin hydrochloride |
Phase II |
MedlinePlus related topics: | Cancer Stomach Cancer |
ChemIDplus related topics: | Docetaxel Epirubicin hydrochloride Epirubicin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach |
Study Start Date: | April 2001 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the stomach
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
France | |||||
American Hospital of Paris | |||||
Neuilly Sur Seine, France, F-92202 | |||||
C.H. Senlis | |||||
Senlis, France, 60309 | |||||
C.H.G. Beauvais | |||||
Beauvais, France, 60021 | |||||
Centre Hospital General Robert Ballanger | |||||
Aulnay Sous Bois, France, 93602 | |||||
Centre Hospital Universitaire Hop Huriez | |||||
Lille, France, 59037 | |||||
Centre Hospitalier Victor Dupouy | |||||
Argenteuil, France, 95107 | |||||
Centre Paul Papin | |||||
Angers, France, 49036 | |||||
CHRU de Tours - Hopital Trousseau | |||||
Tours, France, 37044 | |||||
CHU de la Timone | |||||
Marseille, France, 13385 | |||||
Clinique Saint Jean | |||||
Lyon, France, 69008 | |||||
Clinique Sainte-Marguerite | |||||
Hyeres, France, 83400 | |||||
Maison Medicale Marzet | |||||
Pau, France, 64000 | |||||
Clinique Victor Hugo | |||||
Le Mans, France, F-72000 | |||||
Hopital de la Croix Rousse | |||||
Lyon, France, 69317 | |||||
Hopital d'Instruction des Armes Sainte-Anne | |||||
Toulon, France, 83800 | |||||
Hopital Drevon | |||||
Dijon, France, 21000 | |||||
Hopital Louis Pasteur | |||||
Chartres, France, 28018 | |||||
Hopital Rene Dubos | |||||
Pontoise, France, 95300 | |||||
Hopital Saint Antoine | |||||
Paris, France, 75571 | |||||
Hopital Saint Joseph | |||||
Paris, France, 75674 | |||||
Hopital Tenon | |||||
Paris, France, 75970 | |||||
Intercommunal Hospital | |||||
Montfermeil, France, 93370 | |||||
Clinique Tivoli | |||||
Bordeaux, France, F-33000 |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
Investigator: | Christophe Louvet, MD, PhD | Hopital Saint Antoine |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000346617, FRE-GERCOR-EPITAXD00-1, EU-20326 |
First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075465 |
Health Authority: | United States: Federal Government |
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