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ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer (ZODIAC)

24 de agosto de 2016 actualizado por: Genzyme, a Sanofi Company

A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC

This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.

This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.

All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.

In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.

Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.

Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

1690

Fase

  • Fase 3

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
      • Bad Berka, Alemania
        • Research Site
      • Berlin, Alemania
        • Research Site
      • Essen, Alemania
        • Research Site
      • Großhansdorf, Alemania
        • Research Site
      • Halle, Alemania
        • Research Site
      • Hamburg, Alemania
        • Research Site
      • Heidelberg, Alemania
        • Research Site
      • Köln, Alemania
        • Research Site
      • Oldenburg, Alemania
        • Research Site
      • Ulm, Alemania
        • Research Site
      • Wiesbaden, Alemania
        • Research Site
  • Argentina
      • Bahía Blanca, Argentina
        • Research Site
      • Capital Federal, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
  • Austria
      • Graz, Austria
        • Research Site
      • Grimmenstein, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Linz, Austria
        • Research Site
      • Wels, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Brasil
      • Fortaleza, Brasil
        • Research Site
      • Goiânia, Brasil
        • Research Site
      • Porto Alegre, Brasil
        • Research Site
      • Rio de Janeiro, Brasil
        • Research Site
      • Sao Paulo, Brasil
        • Research Site
  • Bélgica
      • Brussels (Jette), Bélgica
        • Research Site
      • Brussels (Woluwé-St-Lambert), Bélgica
        • Research Site
      • Edegem, Bélgica
        • Research Site
      • Genk, Bélgica
        • Research Site
      • Liege, Bélgica
        • Research Site
  • Canadá
      • Quebec, Canadá
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canadá
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canadá
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá
        • Research Site
    • Ontario
      • Kitchener, Ontario, Canadá
        • Research Site
      • London, Ontario, Canadá
        • Research Site
      • Toronto, Ontario, Canadá
        • Research Site
    • Quebec
      • Laval, Quebec, Canadá
        • Research Site
  • Corea, república de
      • Seoul, Corea, república de
        • Research Site
  • Dinamarca
      • Herlev, Dinamarca
        • Research Site
      • København Ø, Dinamarca
        • Research Site
      • Odense, Dinamarca
        • Research Site
      • Roskilde, Dinamarca
        • Research Site
      • Vejle, Dinamarca
        • Research Site
  • España
      • A Coruña, España
        • Research Site
      • Alicante, España
        • Research Site
      • Madrid, España
        • Research Site
      • Málaga, España
        • Research Site
      • Zaragoza, España
        • Research Site
  • Estados Unidos
    • California
      • Fullerton, California, Estados Unidos
        • Research Site
      • Los Angeles, California, Estados Unidos
        • Research Site
      • Northridge, California, Estados Unidos
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, Estados Unidos
        • Research Site
    • Florida
      • Ocala, Florida, Estados Unidos
        • Research Site
    • Georgia
      • Marietta, Georgia, Estados Unidos
        • Research Site
    • Illinois
      • Joliet, Illinois, Estados Unidos
        • Research Site
      • Park Ridge, Illinois, Estados Unidos
        • Research Site
    • Kansas
      • Hutchinson, Kansas, Estados Unidos
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Estados Unidos
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos
        • Research Site
    • Missouri
      • St. Louis, Missouri, Estados Unidos
        • Research Site
    • Nevada
      • Henderson, Nevada, Estados Unidos
        • Research Site
    • New York
      • Albany, New York, Estados Unidos
        • Research Site
      • Armonk, New York, Estados Unidos
        • Research Site
      • New York, New York, Estados Unidos
        • Research Site
    • North Carolina
      • Durham, North Carolina, Estados Unidos
        • Research Site
      • Hickory, North Carolina, Estados Unidos
        • Research Site
    • Oregon
      • Portland, Oregon, Estados Unidos
        • Research Site
    • Texas
      • Austin, Texas, Estados Unidos
        • Research Site
      • Houston, Texas, Estados Unidos
        • Research Site
    • Utah
      • Ogden, Utah, Estados Unidos
        • Research Site
    • Virginia
      • Alexandria, Virginia, Estados Unidos
        • Research Site
      • Salem, Virginia, Estados Unidos
        • Research Site
    • Washington
      • Vancouver, Washington, Estados Unidos
        • Research Site
  • Francia
      • Bordeaux Cedex, Francia
        • Research Site
      • Boulogne Billancourt, Francia
        • Research Site
      • Caen Cedex, Francia
        • Research Site
      • Dijon, Francia
        • Research Site
      • Nancy, Francia
        • Research Site
      • Paris, Francia
        • Research Site
      • Pierre Benite Cedex, Francia
        • Research Site
      • Saint Herblain, Francia
        • Research Site
  • Grecia
      • Athens, Grecia
        • Research Site
      • Heraklion, Grecia
        • Research Site
  • India
      • Ahmedabad, India
        • Research Site
      • Chennai, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Kolkata, India
        • Research Site
      • New Delhi, India
        • Research Site
      • Pune, India
        • Research Site
      • Vellore, India
        • Research Site
  • Indonesia
      • Jakarta Timur, Indonesia
        • Research Site
      • Yogyakarta, Indonesia
        • Research Site
  • Italia
      • Ancona, Italia
        • Research Site
      • Avellino, Italia
        • Research Site
      • Bologna, Italia
        • Research Site
      • Genova, Italia
        • Research Site
      • Mantova, Italia
        • Research Site
      • Napoli, Italia
        • Research Site
      • Orbassano, Italia
        • Research Site
      • Parma, Italia
        • Research Site
      • Perugia, Italia
        • Research Site
      • Pisa, Italia
        • Research Site
      • Reggio Emilia, Italia
        • Research Site
  • Japón
      • Akashi-shi, Japón
        • Research Site
      • Fukuoka, Japón
        • Research Site
      • Fukuoka-shi, Japón
        • Research Site
      • Isehara-shi, Japón
        • Research Site
      • Kobe-shi, Japón
        • Research Site
      • Koto-ku, Japón
        • Research Site
      • Kumamoto-shi, Japón
        • Research Site
      • Matsuyama-shi, Japón
        • Research Site
      • Nagoya-shi, Japón
        • Research Site
      • Okayama-shi, Japón
        • Research Site
      • Okazaki-shi, Japón
        • Research Site
      • Osaka-shi, Japón
        • Research Site
      • Osakasayama-shi, Japón
        • Research Site
      • Sakai-shi, Japón
        • Research Site
      • Sapporo-shi, Japón
        • Research Site
      • Shinjuku-ku, Japón
        • Research Site
      • Sunto-gun, Japón
        • Research Site
      • Toyonaka, Japón
        • Research Site
      • Ube-shi, Japón
        • Research Site
      • Utsunomiya-shi, Japón
        • Research Site
      • Yokohama-shi, Japón
        • Research Site
  • Malasia
      • Kubang Kerian, Malasia
        • Research Site
      • Nilai, Malasia
        • Research Site
      • Penang, Malasia
        • Research Site
  • México
      • Durango, México
        • Research Site
      • Morelia, México
        • Research Site
      • Toluca, México
        • Research Site
  • Pavo
      • Ankara, Pavo
        • Research Site
      • Istanbul, Pavo
        • Research Site
      • Izmir, Pavo
        • Research Site
  • Países Bajos
      • Amsterdam, Países Bajos
        • Research Site
      • Den Bosch, Países Bajos
        • Research Site
      • Groningen, Países Bajos
        • Research Site
      • Maastricht, Países Bajos
        • Research Site
  • Porcelana
      • Beijing, Porcelana
        • Research Site
      • Chongqing, Porcelana
        • Research Site
      • Guangzhou, Porcelana
        • Research Site
      • Nanjing, Porcelana
        • Research Site
      • Shanghai, Porcelana
        • Research Site
      • Wuhan, Porcelana
        • Research Site
  • Portugal
      • Coimbra, Portugal
        • Research Site
      • Funchal, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Vila Nova de Gaia, Portugal
        • Research Site
  • Singapur
      • Singapore, Singapur
        • Research Site
  • Tailandia
      • Chiang Mai, Tailandia
        • Research Site
  • Vietnam
      • Hanoi city, Vietnam
        • Research Site
      • Ho Chi Minh city, Vietnam
        • 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:

Lung cancer patients who answer true to the following statements are eligible to join this clinical study.

  • I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV)
  • I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed.

Exclusion Criteria:

Lung cancer patients who answer true to the following are NOT eligible to join this clinical study.

  • I do not have non small cell lung cancer (NSCLC)
  • I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable.
  • I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible)
  • I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted.
  • I have a history of uncontrolled irregular heartbeat
  • I have a history of high blood pressure which has not been controlled with medication If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help.

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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 2
Vandetanib + Docetaxel
Droga: Docetaxel
infusion
Otros nombres:
  • TAXOTERE™
Droga: Vandetanib
oral
Otros nombres:
  • ZD6474
  • ZACTIMA®
Comparador activo: 1
Docetaxel monotherapy
Droga: Docetaxel
infusion
Otros nombres:
  • TAXOTERE™

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS) in the Overall Population
Periodo de tiempo: RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months
Progression-Free Survival (PFS) in the Female Population
Periodo de tiempo: RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS) in the Overall Population
Periodo de tiempo: Time to death in months
Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Time to death in months
Overall Survival (OS) in the Female Population
Periodo de tiempo: Time to death in months
Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Time to death in months
Objective Response Rate (ORR)
Periodo de tiempo: Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.
Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Disease Control Rate (DCR)
Periodo de tiempo: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.
RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Duration of Response (DoR)
Periodo de tiempo: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)
RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).
Periodo de tiempo: FACT-L questionnaires are to be administered every 3 weeks after randomisation

The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items.

Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.

A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.
FACT-L questionnaires are to be administered every 3 weeks after randomisation
Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)
Periodo de tiempo: FACT-L questionnaires are to be administered every 3 weeks after randomisation

The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.

Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.

A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.
FACT-L questionnaires are to be administered every 3 weeks after randomisation

Colaboradores e Investigadores

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

Patrocinador

Genzyme, a Sanofi Company

Investigadores

  • Director de estudio: Contact-US@sanofi.com, Sanofi

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

Enlaces Útiles

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 mayo de 2006

Finalización primaria (Actual)

1 de agosto de 2008

Finalización del estudio (Actual)

1 de marzo de 2014

Fechas de registro del estudio

Enviado por primera vez

6 de abril de 2006

Primero enviado que cumplió con los criterios de control de calidad

6 de abril de 2006

Publicado por primera vez (Estimar)

10 de abril de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de septiembre de 2016

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

24 de agosto de 2016

Última verificación

1 de agosto de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D4200C00032
  • 6474IL/0032
  • 2005-004749-32 (Número EudraCT)

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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