- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00075465
Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
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.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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-
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Angers, Frankrig, 49036
- Centre Paul Papin
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Argenteuil, Frankrig, 95107
- Centre Hospitalier Victor Dupouy
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Aulnay Sous Bois, Frankrig, 93602
- Centre Hospital General Robert Ballanger
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Beauvais, Frankrig, 60021
- C.H.G. Beauvais
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Bordeaux, Frankrig, F-33000
- Clinique Tivoli
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Chartres, Frankrig, 28018
- Hôpital Louis Pasteur
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Dijon, Frankrig, 21000
- Hopital Drevon
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Hyeres, Frankrig, 83400
- Clinique Sainte-Marguerite
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Le Mans, Frankrig, F-72000
- Clinique Victor Hugo
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Lille, Frankrig, 59037
- Centre Hospital Universitaire Hop Huriez
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Lyon, Frankrig, 69008
- Clinique Saint Jean
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Lyon, Frankrig, 69317
- Hôpital de la Croix Rousse
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Marseille, Frankrig, 13385
- CHU de la Timone
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Montfermeil, Frankrig, 93370
- Intercommunal Hospital
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Neuilly Sur Seine, Frankrig, F-92202
- American Hospital of Paris
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Paris, Frankrig, 75970
- Hôpital Tenon
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Paris, Frankrig, 75571
- Hôpital Saint Antoine
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Paris, Frankrig, 75674
- Hôpital Saint Joseph
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Pau, Frankrig, 64000
- Maison Medicale Marzet
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Pontoise, Frankrig, 95300
- Hôpital René Dubos
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Senlis, Frankrig, 60309
- C.H. Senlis
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Toulon, Frankrig, 83800
- Hopital d'Instruction des Armes Sainte-Anne
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Tours, Frankrig, 37044
- CHRU de Tours - Hôpital Trousseau
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Objektiv tumorresponsrate
|
Tid til tumorprogression
|
Sekundære resultatmål
Resultatmål |
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Samlet overlevelse
|
Tolerabilitet
|
Survival without local relapse
|
Samarbejdspartnere og efterforskere
Efterforskere
- Christophe Louvet, MD, PhD, Hôpital Saint Antoine
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i maven
- Adenocarcinom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Docetaxel
- Epirubicin
Andre undersøgelses-id-numre
- CDR0000346617
- FRE-GERCOR-EPITAXD00-1
- EU-20326
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Kliniske forsøg med Mavekræft
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Medtronic - MITGAfsluttet
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