Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
NCT ID: NCT00075465
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2001-04-30
Brief Summary
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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.
Detailed Description
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Primary
* Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy.
Secondary
* Determine the survival without local relapse and overall survival of patients treated with this regimen.
* Determine the tolerance to this regimen in these patients.
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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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docetaxel
epirubicin hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the stomach
* Locally advanced or metastatic disease
* Measurable disease
* At least 1 unidimensionally measurable target lesion at least 2 cm in diameter
* No known symptomatic brain metastases
* No bone metastases
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* Bilirubin less than 2 times normal
* AST and ALT no greater than 2.5 times normal
* Alkaline phosphatase no greater than 2.5 times normal
Renal
* Creatinine less than 1.6 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular
* No serious cardiac failure within the past 12 months
* No myocardial infarction within the past 12 months
* No cardiac insufficiency
* No angina
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No uncontrolled serious infection
* No significant brain or psychiatric disorders
* No intolerance to cortisone or polysorbate 80
* No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
* No other illness or medical condition that would preclude study participation
* No peripheral neuropathy greater than grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 21 days since prior participation in another clinical study
* No other concurrent experimental medication
18 Years
75 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
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Christophe Louvet, MD, PhD
Role:
Hopital Saint Antoine
Locations
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Centre Paul Papin
Angers, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Centre Hospital General Robert Ballanger
Aulnay-sous-Bois, , France
C.H.G. Beauvais
Beauvais, , France
Clinique Tivoli
Bordeaux, , France
Hopital Louis Pasteur
Chartres, , France
Hopital Drevon
Dijon, , France
Clinique Sainte-Marguerite
Hyères, , France
Clinique Victor Hugo
Le Mans, , France
Centre Hospital Universitaire Hop Huriez
Lille, , France
Clinique Saint Jean
Lyon, , France
Hopital de la Croix Rousse
Lyon, , France
CHU de la Timone
Marseille, , France
Intercommunal Hospital
Montfermeil, , France
American Hospital of Paris
Neuilly-sur-Seine, , France
Hopital Saint Antoine
Paris, , France
Hopital Saint Joseph
Paris, , France
Hopital Tenon
Paris, , France
Maison Medicale Marzet
Pau, , France
Hopital Rene Dubos
Pontoise, , France
C.H. Senlis
Senlis, , France
Hopital d'Instruction des Armes Sainte-Anne
Toulon, , France
CHRU de Tours - Hopital Trousseau
Tours, , France
Countries
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Other Identifiers
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FRE-GERCOR-EPITAXD00-1
Identifier Type: -
Identifier Source: secondary_id
EU-20326
Identifier Type: -
Identifier Source: secondary_id
CDR0000346617
Identifier Type: -
Identifier Source: org_study_id