Undersøgelse af Alimta og Epirubicin administreret til patienter med lokalt avanceret eller metastatisk brystkræft
18. juli 2006 opdateret af: Eli Lilly and Company
Et fase 2-studie af Alimta og Epirubicin administreret hver 21. dag hos patienter med lokalt avanceret eller metastatisk brystkræft
Dette er en ikke-randomiseret fase 2-del af en undersøgelse, der tester ALIMTA og epirubicin i kombination for lokalt fremskreden eller metastatisk brystkræft.
Epirubicin er et veletableret lægemiddel til behandling af brystkræft.
Både ALIMTA og epirubicin er blevet kombineret med andre lægemidler, men de er endnu ikke blevet kombineret med hinanden.
Det forventes, at patienten vil have gavn af de to lægemidlers forskellige virkningsmekanismer.
Studieoversigt
Undersøgelsestype
Interventionel
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Ciudad De Buenos Aires, Argentina
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Buenos Aires
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La Plata, Buenos Aires, Argentina
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Santa Fe
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Rosario, Santa Fe, Argentina
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Brussels, Belgien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Leuven, Belgien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Wilrijk, Belgien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Sao Paulo, Brasilien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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AL
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Maceio, AL, Brasilien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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BH
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Belo Horizonte, BH, Brasilien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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PR
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Curitiba, PR, Brasilien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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RS
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Porto Alegre, RS, Brasilien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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SP
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Sao Paulo, SP, Brasilien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Sorocaba, SP, Brasilien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Sao Paulo/SP
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Sao Paulo, Sao Paulo/SP, Brasilien
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Col. Campestre Churubusco, Mexico
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Mexico City, Mexico
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Jalisco
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Guadalajara, Jalisco, Mexico
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Mexico D.F.
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Mexico, Mexico D.F., Mexico
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Coimbra, Portugal
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Lisboa, Portugal
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Porto, Portugal
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Proto, Portugal
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Santa Maria Da Feira, Portugal
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Santarem, Portugal
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Alges
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Arquiparque-Miraflores, Alges, Portugal
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (VOKSEN, OLDER_ADULT)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inklusionskriterier:
- Diagnose af lokalt fremskreden eller metastatisk brystkræft, der ikke er modtagelig for lokal behandling.
- Patienter skal være kemo-naive eller kun have neoadjuverende og/eller adjuverende kemoterapi.
- Patienter skal have mindst én målbar læsion i et område, der ikke tidligere er bestrålet.
- Ingen kemoterapi mindst 4 uger før studieindskrivning.
- Underskrevet informeret samtykke fra patient.
Ekskluderingskriterier:
- Behandling med ethvert lægemiddel inden for de sidste 30 dage, som ikke har modtaget myndighedsgodkendelse.
- Alvorlige systemiske lidelser, herunder aktiv infektion.
- Betydelig hjerte-kar-sygdom.
- Graviditet eller amning.
- Manglende evne eller vilje til at tage folinsyre eller vitamin B12-tilskud.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
- Tildeling: NON_RANDOMIZED
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Datoer for studieregistrering
Først indsendt
22. november 2004
Først indsendt, der opfyldte QC-kriterier
22. november 2004
Først opslået (SKØN)
23. november 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (SKØN)
19. juli 2006
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juli 2006
Sidst verificeret
1. juli 2006
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4028
- H3E-MC-JMDU
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .