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Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC) (OPUS)

5. august 2014 oppdatert av: Merck KGaA, Darmstadt, Germany

Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer

This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

344

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Antwerpen, Belgia
        • Research Site
      • Bonheiden, Belgia
        • Research Site
      • Brugge, Belgia
        • Research Site
      • Hasselt, Belgia
        • Research Site
      • Leuven, Belgia
        • Research Site
      • Roeselare, Belgia
        • Research Site
      • Turnhout, Belgia
        • Research Site
      • ZU Gent, Belgia
        • Research Site
  • Den russiske føderasjonen
      • Kazan, Den russiske føderasjonen
        • Research Site
      • Krasnodar, Den russiske føderasjonen
        • Research Site
      • Moscow, Den russiske føderasjonen
        • Research Site
      • Obninsk, Den russiske føderasjonen
        • Research Site
      • Samara, Den russiske føderasjonen
        • Research Site
      • St. Petersburg, Den russiske føderasjonen
        • Research Site
  • Frankrike
      • Besancon, Frankrike
        • Research Site
      • Clermond Ferrand, Frankrike
        • Research Site
      • Clichy, Frankrike
        • Research Site
      • Montpellier, Frankrike
        • Research Site
      • Paris, Frankrike
        • Research Site
      • Rouen, Frankrike
        • Research Site
      • Strasbourg, Frankrike
        • Research Site
  • Hellas
      • Athens, Hellas
        • Research Site
      • Loannina, Hellas
        • Research Site
      • Thessaloniki, Hellas
        • Research Site
  • Israel
      • Haifa, Israel
        • Research Site
      • Kfar-Saba, Israel
        • Research Site
      • Petah Tiqva, Israel
        • Research Site
      • Rehovot, Israel
        • Research Site
      • Tel-Aviv, Israel
        • Research Site
      • Tel-Hashomer, Israel
        • Research Site
  • Italia
      • Brescia, Italia
        • Research Site
      • Milano, Italia
        • Research Site
      • Padova, Italia
        • Research Site
      • Pavia, Italia
        • Research Site
      • Rome, Italia
        • Research Site
      • Torino, Italia
        • Research Site
  • Polen
      • Bialystok, Polen
        • Research Site
      • Krakow, Polen
        • Research Site
      • Lublin, Polen
        • Research Site
      • Opole, Polen
        • Research Site
      • Poznan, Polen
        • Research Site
      • Szczecin, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
  • Portugal
      • Lisbon, Portugal
        • Research Site
      • Santa Maira da Feira, Portugal
        • Research Site
  • Romania
      • Alba Iulia, Romania
        • Research Site
      • Bucurest, Romania
        • Research Site
      • Onesti, Romania
        • Research Site
      • Oradea, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
  • Spania
      • Bilbao, Spania
        • Research Site
      • Burgos, Spania
        • Research Site
      • Girona, Spania
        • Research Site
      • Madrid, Spania
        • Research Site
      • Malaga, Spania
        • Research Site
      • Orense, Spania
        • Research Site
      • Reus, Spania
        • Research Site
      • Valencia, Spania
        • Research Site
  • Tyskland
      • Aschaffenburg, Tyskland
        • Research Site
      • Dresden, Tyskland
        • Research Site
      • Essen, Tyskland
        • Research Site
      • Hamburg, Tyskland
        • Research Site
      • Kiel, Tyskland
        • Research Site
      • Magdeburg, Tyskland
        • Research Site
      • Mannheim, Tyskland
        • Research Site
      • Nürnberg, Tyskland
        • Research Site
      • Tübingen, Tyskland
        • Research Site
  • Ukraina
      • Dnepropetrovsk, Ukraina
        • Research Site
      • Kharkov, Ukraina
        • Research Site
      • Kiev, Ukraina
        • Research Site
      • Lviv, Ukraina
        • Research Site
      • Simferopol, Ukraina
        • Research Site
      • Vinnitsa, Ukraina
        • Research Site
  • Østerrike
      • Graz, Østerrike
        • Research Site
      • Linz, Østerrike
        • Research Site
      • Salzburg, Østerrike
        • Research Site
      • Wien, Østerrike
        • Research Site
      • Zams, Østerrike
        • 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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • First-line mCRC
  • EGFR positive
  • Bi-dimensional measurable index lesion

Exclusion Criteria:

  • Previous exposure to EGFR-targeting therapy
  • Previous oxaliplatin-based therapy
  • Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
  • Radiotherapy
  • Surgery
  • Any other investigational drug in the 30 days before randomization
  • Brain metastasis and/or leptomeningeal disease
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cetuximab Plus FOLFOX-4
Biologisk: Cetuximab

Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops
Aktiv komparator: FOLFOX-4 Alone
Legemiddel: Oxaliplatin

Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Best Overall Response Rate - Independent Review Committee (IRC)
Tidsramme: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)
Tidsramme: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
Best Overall Response Rate (KRAS Mutant Population)
Tidsramme: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
Progression-free Survival Time
Tidsramme: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007
Progression-free Survival Time (KRAS Wild-Type Population)
Tidsramme: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Progression-free Survival Time (KRAS Mutant Population)
Tidsramme: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Overall Survival Time
Tidsramme: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Overall Survival Time (KRAS Wild-Type Population)
Tidsramme: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Overall Survival Time (KRAS Mutant Population)
Tidsramme: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Participants With No Residual Tumor After Metastatic Surgery
Tidsramme: Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
No residual tumor after on-study surgery for metastases.
Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Disease Control Rate (Cut Off Date 4 August 2006)
Tidsramme: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments as assessed by IRC (based on modified WHO criteria).
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
Duration of Response
Tidsramme: Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007

Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).

Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007
Safety - Number of Patients Experiencing Any Adverse Event
Tidsramme: time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008
Please refer to Adverse Events section for further details
time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008

Samarbeidspartnere og etterforskere

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

Sponsor

Merck KGaA, Darmstadt, Germany

Etterforskere

  • Hovedetterforsker: Bokemeyer, Prof. Dr., Klinik für Onkologie, Hämatologie und Knochenmarktransplantationen Universitätsklinikum Hamburg-Eppendorf, Germany

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

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. juli 2005

Primær fullføring (Faktiske)

1. mars 2007

Studiet fullført (Faktiske)

1. november 2010

Datoer for studieregistrering

Først innsendt

28. juli 2005

Først innsendt som oppfylte QC-kriteriene

28. juli 2005

Først lagt ut (Anslag)

29. juli 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. august 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2014

Sist bekreftet

1. august 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EMR 62202-047

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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