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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 agosto 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1690

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Belgio
      • Brussels (Jette), Belgio
        • Research Site
      • Brussels (Woluwé-St-Lambert), Belgio
        • Research Site
      • Edegem, Belgio
        • Research Site
      • Genk, Belgio
        • Research Site
      • Liege, Belgio
        • Research Site
  • Brasile
      • Fortaleza, Brasile
        • Research Site
      • Goiânia, Brasile
        • Research Site
      • Porto Alegre, Brasile
        • Research Site
      • Rio de Janeiro, Brasile
        • Research Site
      • Sao Paulo, Brasile
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Kitchener, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Laval, Quebec, Canada
        • Research Site
  • Cina
      • Beijing, Cina
        • Research Site
      • Chongqing, Cina
        • Research Site
      • Guangzhou, Cina
        • Research Site
      • Nanjing, Cina
        • Research Site
      • Shanghai, Cina
        • Research Site
      • Wuhan, Cina
        • Research Site
  • Corea, Repubblica di
      • Seoul, Corea, Repubblica di
        • Research Site
  • Danimarca
      • Herlev, Danimarca
        • Research Site
      • København Ø, Danimarca
        • Research Site
      • Odense, Danimarca
        • Research Site
      • Roskilde, Danimarca
        • Research Site
      • Vejle, Danimarca
        • 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
  • Germania
      • Bad Berka, Germania
        • Research Site
      • Berlin, Germania
        • Research Site
      • Essen, Germania
        • Research Site
      • Großhansdorf, Germania
        • Research Site
      • Halle, Germania
        • Research Site
      • Hamburg, Germania
        • Research Site
      • Heidelberg, Germania
        • Research Site
      • Köln, Germania
        • Research Site
      • Oldenburg, Germania
        • Research Site
      • Ulm, Germania
        • Research Site
      • Wiesbaden, Germania
        • Research Site
  • Giappone
      • Akashi-shi, Giappone
        • Research Site
      • Fukuoka, Giappone
        • Research Site
      • Fukuoka-shi, Giappone
        • Research Site
      • Isehara-shi, Giappone
        • Research Site
      • Kobe-shi, Giappone
        • Research Site
      • Koto-ku, Giappone
        • Research Site
      • Kumamoto-shi, Giappone
        • Research Site
      • Matsuyama-shi, Giappone
        • Research Site
      • Nagoya-shi, Giappone
        • Research Site
      • Okayama-shi, Giappone
        • Research Site
      • Okazaki-shi, Giappone
        • Research Site
      • Osaka-shi, Giappone
        • Research Site
      • Osakasayama-shi, Giappone
        • Research Site
      • Sakai-shi, Giappone
        • Research Site
      • Sapporo-shi, Giappone
        • Research Site
      • Shinjuku-ku, Giappone
        • Research Site
      • Sunto-gun, Giappone
        • Research Site
      • Toyonaka, Giappone
        • Research Site
      • Ube-shi, Giappone
        • Research Site
      • Utsunomiya-shi, Giappone
        • Research Site
      • Yokohama-shi, Giappone
        • 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
  • Malaysia
      • Kubang Kerian, Malaysia
        • Research Site
      • Nilai, Malaysia
        • Research Site
      • Penang, Malaysia
        • Research Site
  • Messico
      • Durango, Messico
        • Research Site
      • Morelia, Messico
        • Research Site
      • Toluca, Messico
        • Research Site
  • Olanda
      • Amsterdam, Olanda
        • Research Site
      • Den Bosch, Olanda
        • Research Site
      • Groningen, Olanda
        • Research Site
      • Maastricht, Olanda
        • Research Site
  • Portogallo
      • Coimbra, Portogallo
        • Research Site
      • Funchal, Portogallo
        • Research Site
      • Lisboa, Portogallo
        • Research Site
      • Porto, Portogallo
        • Research Site
      • Vila Nova de Gaia, Portogallo
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • Spagna
      • A Coruña, Spagna
        • Research Site
      • Alicante, Spagna
        • Research Site
      • Madrid, Spagna
        • Research Site
      • Málaga, Spagna
        • Research Site
      • Zaragoza, Spagna
        • Research Site
  • Stati Uniti
    • California
      • Fullerton, California, Stati Uniti
        • Research Site
      • Los Angeles, California, Stati Uniti
        • Research Site
      • Northridge, California, Stati Uniti
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Stati Uniti
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, Stati Uniti
        • Research Site
    • Florida
      • Ocala, Florida, Stati Uniti
        • Research Site
    • Georgia
      • Marietta, Georgia, Stati Uniti
        • Research Site
    • Illinois
      • Joliet, Illinois, Stati Uniti
        • Research Site
      • Park Ridge, Illinois, Stati Uniti
        • Research Site
    • Kansas
      • Hutchinson, Kansas, Stati Uniti
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Stati Uniti
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti
        • Research Site
    • Missouri
      • St. Louis, Missouri, Stati Uniti
        • Research Site
    • Nevada
      • Henderson, Nevada, Stati Uniti
        • Research Site
    • New York
      • Albany, New York, Stati Uniti
        • Research Site
      • Armonk, New York, Stati Uniti
        • Research Site
      • New York, New York, Stati Uniti
        • Research Site
    • North Carolina
      • Durham, North Carolina, Stati Uniti
        • Research Site
      • Hickory, North Carolina, Stati Uniti
        • Research Site
    • Oregon
      • Portland, Oregon, Stati Uniti
        • Research Site
    • Texas
      • Austin, Texas, Stati Uniti
        • Research Site
      • Houston, Texas, Stati Uniti
        • Research Site
    • Utah
      • Ogden, Utah, Stati Uniti
        • Research Site
    • Virginia
      • Alexandria, Virginia, Stati Uniti
        • Research Site
      • Salem, Virginia, Stati Uniti
        • Research Site
    • Washington
      • Vancouver, Washington, Stati Uniti
        • Research Site
  • Tacchino
      • Ankara, Tacchino
        • Research Site
      • Istanbul, Tacchino
        • Research Site
      • Izmir, Tacchino
        • Research Site
  • Tailandia
      • Chiang Mai, Tailandia
        • Research Site
  • Vietnam
      • Hanoi city, Vietnam
        • Research Site
      • Ho Chi Minh city, Vietnam
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 2
Vandetanib + Docetaxel
Droga: Docetaxel
infusion
Altri nomi:
  • TAXOTERE™
Droga: Vandetanib
oral
Altri nomi:
  • ZD6474
  • ZACTIMA®
Comparatore attivo: 1
Docetaxel monotherapy
Droga: Docetaxel
infusion
Altri nomi:
  • TAXOTERE™

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival (PFS) in the Overall Population
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS) in the Overall Population
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Genzyme, a Sanofi Company

Investigatori

  • Direttore dello studio: Contact-US@sanofi.com, Sanofi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2006

Completamento primario (Effettivo)

1 agosto 2008

Completamento dello studio (Effettivo)

1 marzo 2014

Date di iscrizione allo studio

Primo inviato

6 aprile 2006

Primo inviato che soddisfa i criteri di controllo qualità

6 aprile 2006

Primo Inserito (Stima)

10 aprile 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 settembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 agosto 2016

Ultimo verificato

1 agosto 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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