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

5 de agosto de 2014 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

344

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Aschaffenburg, Alemania
        • Research Site
      • Dresden, Alemania
        • Research Site
      • Essen, Alemania
        • Research Site
      • Hamburg, Alemania
        • Research Site
      • Kiel, Alemania
        • Research Site
      • Magdeburg, Alemania
        • Research Site
      • Mannheim, Alemania
        • Research Site
      • Nürnberg, Alemania
        • Research Site
      • Tübingen, Alemania
        • Research Site
  • Austria
      • Graz, Austria
        • Research Site
      • Linz, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Wien, Austria
        • Research Site
      • Zams, Austria
        • Research Site
  • Bélgica
      • Antwerpen, Bélgica
        • Research Site
      • Bonheiden, Bélgica
        • Research Site
      • Brugge, Bélgica
        • Research Site
      • Hasselt, Bélgica
        • Research Site
      • Leuven, Bélgica
        • Research Site
      • Roeselare, Bélgica
        • Research Site
      • Turnhout, Bélgica
        • Research Site
      • ZU Gent, Bélgica
        • Research Site
  • España
      • Bilbao, España
        • Research Site
      • Burgos, España
        • Research Site
      • Girona, España
        • Research Site
      • Madrid, España
        • Research Site
      • Malaga, España
        • Research Site
      • Orense, España
        • Research Site
      • Reus, España
        • Research Site
      • Valencia, España
        • Research Site
  • Federación Rusa
      • Kazan, Federación Rusa
        • Research Site
      • Krasnodar, Federación Rusa
        • Research Site
      • Moscow, Federación Rusa
        • Research Site
      • Obninsk, Federación Rusa
        • Research Site
      • Samara, Federación Rusa
        • Research Site
      • St. Petersburg, Federación Rusa
        • Research Site
  • Francia
      • Besancon, Francia
        • Research Site
      • Clermond Ferrand, Francia
        • Research Site
      • Clichy, Francia
        • Research Site
      • Montpellier, Francia
        • Research Site
      • Paris, Francia
        • Research Site
      • Rouen, Francia
        • Research Site
      • Strasbourg, Francia
        • Research Site
  • Grecia
      • Athens, Grecia
        • Research Site
      • Loannina, Grecia
        • Research Site
      • Thessaloniki, Grecia
        • 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
  • Polonia
      • Bialystok, Polonia
        • Research Site
      • Krakow, Polonia
        • Research Site
      • Lublin, Polonia
        • Research Site
      • Opole, Polonia
        • Research Site
      • Poznan, Polonia
        • Research Site
      • Szczecin, Polonia
        • Research Site
      • Warszawa, Polonia
        • Research Site
  • Portugal
      • Lisbon, Portugal
        • Research Site
      • Santa Maira da Feira, Portugal
        • Research Site
  • Rumania
      • Alba Iulia, Rumania
        • Research Site
      • Bucurest, Rumania
        • Research Site
      • Onesti, Rumania
        • Research Site
      • Oradea, Rumania
        • Research Site
      • Timisoara, Rumania
        • Research Site
  • Ucrania
      • Dnepropetrovsk, Ucrania
        • Research Site
      • Kharkov, Ucrania
        • Research Site
      • Kiev, Ucrania
        • Research Site
      • Lviv, Ucrania
        • Research Site
      • Simferopol, Ucrania
        • Research Site
      • Vinnitsa, Ucrania
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cetuximab Plus FOLFOX-4
Biológico: 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
Comparador activo: FOLFOX-4 Alone
Droga: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Best Overall Response Rate - Independent Review Committee (IRC)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Merck KGaA, Darmstadt, Germany

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2005

Finalización primaria (Actual)

1 de marzo de 2007

Finalización del estudio (Actual)

1 de noviembre de 2010

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2005

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2005

Publicado por primera vez (Estimar)

29 de julio de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de agosto de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

5 de agosto de 2014

Última verificación

1 de agosto de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • EMR 62202-047

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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