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Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer (HORIZON II)

7. november 2016 opdateret af: AstraZeneca

A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.

The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1254

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires City, Argentina
        • Research Site
      • Capital Federal, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Resistencia, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
  • Australien
      • Ashford, Australien
        • Research Site
      • Camperdown, Australien
        • Research Site
      • Heidelberg, Australien
        • Research Site
      • Hornsby, Australien
        • Research Site
      • Liverpool, Australien
        • Research Site
      • Waratah, Australien
        • Research Site
      • Wodonga, Australien
        • Research Site
  • Brasilien
      • Curitiba, Brasilien
        • Research Site
      • Goiânia, Brasilien
        • Research Site
      • Jaú, Brasilien
        • Research Site
      • Porto Alegre, Brasilien
        • Research Site
      • Rio de Janeiro, Brasilien
        • Research Site
      • Salvador, Brasilien
        • Research Site
      • Santo André, Brasilien
        • Research Site
      • Sao Paulo, Brasilien
        • Research Site
      • São Paulo, Brasilien
        • Research Site
  • Bulgarien
      • Plovdiv, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Site
      • Stara Zagora, Bulgarien
        • Research Site
      • Varna, Bulgarien
        • Research Site
      • Veliko Tarnovo, Bulgarien
        • Research Site
      • Vratza, Bulgarien
        • Research Site
  • Det Forenede Kongerige
      • Aberdeen, Det Forenede Kongerige
        • Research Site
      • Belfast, Det Forenede Kongerige
        • Research Site
      • Leicester, Det Forenede Kongerige
        • Research Site
      • Manchester, Det Forenede Kongerige
        • Research Site
  • Filippinerne
      • Cebu City, Filippinerne
        • Research Site
      • Davao City, Filippinerne
        • Research Site
      • Iloilo, Filippinerne
        • Research Site
      • Quezon, Filippinerne
        • Research Site
      • Quezon City, Filippinerne
        • Research Site
  • Indien
      • Hyderabad, Indien
        • Research Site
      • Trivandrum, Indien
        • Research Site
  • Kina
      • Beijing, Kina
        • Research Site
      • Changchun, Kina
        • Research Site
      • Chengdu, Kina
        • Research Site
      • ChongQing, Kina
        • Research Site
      • Fuzhou, Kina
        • Research Site
      • Guangzhou, Kina
        • Research Site
      • Hangzhou, Kina
        • Research Site
      • Nanjing, Kina
        • Research Site
      • Nanning, Kina
        • Research Site
      • Shanghai, Kina
        • Research Site
      • Tianjin, Kina
        • Research Site
  • Korea, Republikken
      • Goyang-si, Korea, Republikken
        • Research Site
      • Seoul, Korea, Republikken
        • Research Site
  • Polen
      • Bydgoszcz, Polen
        • Research Site
      • Gdańsk, Polen
        • Research Site
      • Gliwice, Polen
        • Research Site
      • Kraków, Polen
        • Research Site
      • Olsztyn, Polen
        • Research Site
      • Toruń, Polen
        • Research Site
      • Wrocław, Polen
        • Research Site
  • Schweiz
      • Bellinzona, Schweiz
        • Research Site
      • Lausanne, Schweiz
        • Research Site
      • Locarno, Schweiz
        • Research Site
      • Zürich, Schweiz
        • Research Site
  • Taiwan
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
  • Tjekkiet
      • Brno, Tjekkiet
        • Research Site
      • Ceske Budejovice, Tjekkiet
        • Research Site
      • Cheb, Tjekkiet
        • Research Site
      • Jicin, Tjekkiet
        • Research Site
      • Jihlava, Tjekkiet
        • Research Site
      • Olomouc, Tjekkiet
        • Research Site
      • Ostrava, Tjekkiet
        • Research Site
      • Praha 6, Tjekkiet
        • Research Site
      • Pribram - Zdabor, Tjekkiet
        • Research Site
      • Sumperk, Tjekkiet
        • Research Site
      • Zlin, Tjekkiet
        • Research Site
      • Znojmo, Tjekkiet
        • Research Site
  • Tyskland
      • Essen, Tyskland
        • Research Site
      • Freiburg, Tyskland
        • Research Site
      • Goslar, Tyskland
        • Research Site
      • Hamburg, Tyskland
        • Research Site
      • Hildesheim, Tyskland
        • Research Site
      • Mannheim, Tyskland
        • Research Site
  • Ungarn
      • Budapest, Ungarn
        • Research Site
      • Debrecen, Ungarn
        • Research Site
      • Györ, Ungarn
        • Research Site
      • Kecskemét, Ungarn
        • Research Site
      • Nyíregyháza, Ungarn
        • Research Site
      • Szombathely, Ungarn
        • Research Site
      • Zalaegerszeg, Ungarn
        • Research Site

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 til 130 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Written Informed Consent
  • Carcinoma of the colon or rectum
  • One or more measurable lesions

Exclusion Criteria:

  • Adjuvant/neoadjuvant therapy within 6-12 months of study entry
  • Untreated unstable brain or meningeal metastases
  • Specific laboratory ranges
  • Specific cardiovascular problems
  • Participation in other trials within 30 days

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: FOLFOX + placebo Cediranib
Medicin: Cediranib Placebo
oral tablet
Medicin: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenøs infusion
Andre navne:
  • 5-FU
  • Andre navne:
  • Eloxatin®
  • Lægemiddel: Leucovorin (i FOLFOX)
  • intravenøs infusion
  • Lægemiddel: Oxaliplatin (i FOLFOX)
Placebo komparator: Xelox + placebo Cediranib
Medicin: Cediranib Placebo
oral tablet
Medicin: XELOX (Capecitabine and Oxaliplatin)
intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15)
Andre navne:
  • Xeloda® + Eloxatin®
Eksperimentel: FOLFOX + Cediranib
Medicin: Cediranib
oral tablet
Andre navne:
  • RECENTIN™
  • AZD2171
Medicin: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenøs infusion
Andre navne:
  • 5-FU
  • Andre navne:
  • Eloxatin®
  • Lægemiddel: Leucovorin (i FOLFOX)
  • intravenøs infusion
  • Lægemiddel: Oxaliplatin (i FOLFOX)
Eksperimentel: XELOX + Cediranib
Medicin: Cediranib
oral tablet
Andre navne:
  • RECENTIN™
  • AZD2171
Medicin: XELOX (Capecitabine and Oxaliplatin)
intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15)
Andre navne:
  • Xeloda® + Eloxatin®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival
Tidsramme: RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.
RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
Overall Survival
Tidsramme: Baseline through to date of death upto and including data cut off date of 21/03/10
Number of months from randomisation to the date of death from any cause
Baseline through to date of death upto and including data cut off date of 21/03/10

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate
Tidsramme: Baseline through to date of death upto and including data cut off date of 21/03/10
Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi
Baseline through to date of death upto and including data cut off date of 21/03/10
Best Percentage Change in Tumour Size
Tidsramme: Baseline through to date of death upto and including data cut off date of 21/03/10
Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions
Baseline through to date of death upto and including data cut off date of 21/03/10
Duration of Response
Tidsramme: Treatment period from initial response up until data cut-off date of 21/03/10
Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.
Treatment period from initial response up until data cut-off date of 21/03/10
Rate of Resection of Liver Metastases
Tidsramme: Post-randomisation until end of study
Number of patients undergoing liver resection, based on patients with liver disease at baseline
Post-randomisation until end of study
Time to Wound Healing Complications
Tidsramme: Post-randomisation until end of study
Number of days from post-randomisation surgery until wound healing complications
Post-randomisation until end of study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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.

Studer store datoer

Studiestart

1. november 2006

Primær færdiggørelse (Faktiske)

1. marts 2010

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

13. november 2006

Først indsendt, der opfyldte QC-kriterier

13. november 2006

Først opslået (Skøn)

14. november 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D8480C00051
  • EUDRACT No 2006-001194-14
  • HORIZON II

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 .

Kliniske forsøg med Metastatisk tyktarmskræft

Kliniske forsøg med Cediranib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Indonesia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner