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

7. november 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1254

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Australia
      • Ashford, Australia
        • Research Site
      • Camperdown, Australia
        • Research Site
      • Heidelberg, Australia
        • Research Site
      • Hornsby, Australia
        • Research Site
      • Liverpool, Australia
        • Research Site
      • Waratah, Australia
        • Research Site
      • Wodonga, Australia
        • Research Site
  • Brasil
      • Curitiba, Brasil
        • Research Site
      • Goiânia, Brasil
        • Research Site
      • Jaú, Brasil
        • Research Site
      • Porto Alegre, Brasil
        • Research Site
      • Rio de Janeiro, Brasil
        • Research Site
      • Salvador, Brasil
        • Research Site
      • Santo André, Brasil
        • Research Site
      • Sao Paulo, Brasil
        • Research Site
      • São Paulo, Brasil
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
      • Veliko Tarnovo, Bulgaria
        • Research Site
      • Vratza, Bulgaria
        • Research Site
  • Filippinene
      • Cebu City, Filippinene
        • Research Site
      • Davao City, Filippinene
        • Research Site
      • Iloilo, Filippinene
        • Research Site
      • Quezon, Filippinene
        • Research Site
      • Quezon City, Filippinene
        • Research Site
  • India
      • Hyderabad, India
        • Research Site
      • Trivandrum, India
        • 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
  • Storbritannia
      • Aberdeen, Storbritannia
        • Research Site
      • Belfast, Storbritannia
        • Research Site
      • Leicester, Storbritannia
        • Research Site
      • Manchester, Storbritannia
        • Research Site
  • Sveits
      • Bellinzona, Sveits
        • Research Site
      • Lausanne, Sveits
        • Research Site
      • Locarno, Sveits
        • Research Site
      • Zürich, Sveits
        • Research Site
  • Taiwan
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
  • Tsjekkisk Republikk
      • Brno, Tsjekkisk Republikk
        • Research Site
      • Ceske Budejovice, Tsjekkisk Republikk
        • Research Site
      • Cheb, Tsjekkisk Republikk
        • Research Site
      • Jicin, Tsjekkisk Republikk
        • Research Site
      • Jihlava, Tsjekkisk Republikk
        • Research Site
      • Olomouc, Tsjekkisk Republikk
        • Research Site
      • Ostrava, Tsjekkisk Republikk
        • Research Site
      • Praha 6, Tsjekkisk Republikk
        • Research Site
      • Pribram - Zdabor, Tsjekkisk Republikk
        • Research Site
      • Sumperk, Tsjekkisk Republikk
        • Research Site
      • Zlin, Tsjekkisk Republikk
        • Research Site
      • Znojmo, Tsjekkisk Republikk
        • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 130 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: FOLFOX + placebo Cediranib
Legemiddel: Cediranib Placebo
oral tablett
Legemiddel: FOLFOX (5-fluorouracil, leucovorin, oksaliplatin)
intravenøs infusjon
Andre navn:
  • 5-FU
  • Andre navn:
  • Eloxatin®
  • Legemiddel: Leucovorin (i FOLFOX)
  • intravenøs infusjon
  • Legemiddel: Oksaliplatin (i FOLFOX)
Placebo komparator: Xelox + placebo Cediranib
Legemiddel: Cediranib Placebo
oral tablett
Legemiddel: 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 navn:
  • Xeloda® + Eloxatin®
Eksperimentell: FOLFOX + Cediranib
Legemiddel: Cediranib
oral tablett
Andre navn:
  • RECENTIN™
  • AZD2171
Legemiddel: FOLFOX (5-fluorouracil, leucovorin, oksaliplatin)
intravenøs infusjon
Andre navn:
  • 5-FU
  • Andre navn:
  • Eloxatin®
  • Legemiddel: Leucovorin (i FOLFOX)
  • intravenøs infusjon
  • Legemiddel: Oksaliplatin (i FOLFOX)
Eksperimentell: XELOX + Cediranib
Legemiddel: Cediranib
oral tablett
Andre navn:
  • RECENTIN™
  • AZD2171
Legemiddel: 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 navn:
  • Xeloda® + Eloxatin®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2006

Primær fullføring (Faktiske)

1. mars 2010

Studiet fullført (Faktiske)

1. august 2016

Datoer for studieregistrering

Først innsendt

13. november 2006

Først innsendt som oppfylte QC-kriteriene

13. november 2006

Først lagt ut (Anslag)

14. november 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. desember 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. november 2016

Sist bekreftet

1. oktober 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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