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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. august 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1690

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Belgien
      • Brussels (Jette), Belgien
        • Research Site
      • Brussels (Woluwé-St-Lambert), Belgien
        • Research Site
      • Edegem, Belgien
        • Research Site
      • Genk, Belgien
        • Research Site
      • Liege, Belgien
        • Research Site
  • Brasilien
      • Fortaleza, Brasilien
        • Research Site
      • Goiânia, Brasilien
        • Research Site
      • Porto Alegre, Brasilien
        • Research Site
      • Rio de Janeiro, Brasilien
        • Research Site
      • Sao Paulo, Brasilien
        • 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
  • Danmark
      • Herlev, Danmark
        • Research Site
      • København Ø, Danmark
        • Research Site
      • Odense, Danmark
        • Research Site
      • Roskilde, Danmark
        • Research Site
      • Vejle, Danmark
        • Research Site
  • Forenede Stater
    • California
      • Fullerton, California, Forenede Stater
        • Research Site
      • Los Angeles, California, Forenede Stater
        • Research Site
      • Northridge, California, Forenede Stater
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, Forenede Stater
        • Research Site
    • Florida
      • Ocala, Florida, Forenede Stater
        • Research Site
    • Georgia
      • Marietta, Georgia, Forenede Stater
        • Research Site
    • Illinois
      • Joliet, Illinois, Forenede Stater
        • Research Site
      • Park Ridge, Illinois, Forenede Stater
        • Research Site
    • Kansas
      • Hutchinson, Kansas, Forenede Stater
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
        • Research Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater
        • Research Site
    • Nevada
      • Henderson, Nevada, Forenede Stater
        • Research Site
    • New York
      • Albany, New York, Forenede Stater
        • Research Site
      • Armonk, New York, Forenede Stater
        • Research Site
      • New York, New York, Forenede Stater
        • Research Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater
        • Research Site
      • Hickory, North Carolina, Forenede Stater
        • Research Site
    • Oregon
      • Portland, Oregon, Forenede Stater
        • Research Site
    • Texas
      • Austin, Texas, Forenede Stater
        • Research Site
      • Houston, Texas, Forenede Stater
        • Research Site
    • Utah
      • Ogden, Utah, Forenede Stater
        • Research Site
    • Virginia
      • Alexandria, Virginia, Forenede Stater
        • Research Site
      • Salem, Virginia, Forenede Stater
        • Research Site
    • Washington
      • Vancouver, Washington, Forenede Stater
        • Research Site
  • Frankrig
      • Bordeaux Cedex, Frankrig
        • Research Site
      • Boulogne Billancourt, Frankrig
        • Research Site
      • Caen Cedex, Frankrig
        • Research Site
      • Dijon, Frankrig
        • Research Site
      • Nancy, Frankrig
        • Research Site
      • Paris, Frankrig
        • Research Site
      • Pierre Benite Cedex, Frankrig
        • Research Site
      • Saint Herblain, Frankrig
        • Research Site
  • Grækenland
      • Athens, Grækenland
        • Research Site
      • Heraklion, Grækenland
        • Research Site
  • Holland
      • Amsterdam, Holland
        • Research Site
      • Den Bosch, Holland
        • Research Site
      • Groningen, Holland
        • Research Site
      • Maastricht, Holland
        • Research Site
  • Indien
      • Ahmedabad, Indien
        • Research Site
      • Chennai, Indien
        • Research Site
      • Hyderabad, Indien
        • Research Site
      • Kolkata, Indien
        • Research Site
      • New Delhi, Indien
        • Research Site
      • Pune, Indien
        • Research Site
      • Vellore, Indien
        • Research Site
  • Indonesien
      • Jakarta Timur, Indonesien
        • Research Site
      • Yogyakarta, Indonesien
        • Research Site
  • Italien
      • Ancona, Italien
        • Research Site
      • Avellino, Italien
        • Research Site
      • Bologna, Italien
        • Research Site
      • Genova, Italien
        • Research Site
      • Mantova, Italien
        • Research Site
      • Napoli, Italien
        • Research Site
      • Orbassano, Italien
        • Research Site
      • Parma, Italien
        • Research Site
      • Perugia, Italien
        • Research Site
      • Pisa, Italien
        • Research Site
      • Reggio Emilia, Italien
        • Research Site
  • Japan
      • Akashi-shi, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Fukuoka-shi, Japan
        • Research Site
      • Isehara-shi, Japan
        • Research Site
      • Kobe-shi, Japan
        • Research Site
      • Koto-ku, Japan
        • Research Site
      • Kumamoto-shi, Japan
        • Research Site
      • Matsuyama-shi, Japan
        • Research Site
      • Nagoya-shi, Japan
        • Research Site
      • Okayama-shi, Japan
        • Research Site
      • Okazaki-shi, Japan
        • Research Site
      • Osaka-shi, Japan
        • Research Site
      • Osakasayama-shi, Japan
        • Research Site
      • Sakai-shi, Japan
        • Research Site
      • Sapporo-shi, Japan
        • Research Site
      • Shinjuku-ku, Japan
        • Research Site
      • Sunto-gun, Japan
        • Research Site
      • Toyonaka, Japan
        • Research Site
      • Ube-shi, Japan
        • Research Site
      • Utsunomiya-shi, Japan
        • Research Site
      • Yokohama-shi, Japan
        • Research Site
  • Kalkun
      • Ankara, Kalkun
        • Research Site
      • Istanbul, Kalkun
        • Research Site
      • Izmir, Kalkun
        • Research Site
  • Kina
      • Beijing, Kina
        • Research Site
      • Chongqing, Kina
        • Research Site
      • Guangzhou, Kina
        • Research Site
      • Nanjing, Kina
        • Research Site
      • Shanghai, Kina
        • Research Site
      • Wuhan, Kina
        • Research Site
  • Korea, Republikken
      • Seoul, Korea, Republikken
        • Research Site
  • Malaysia
      • Kubang Kerian, Malaysia
        • Research Site
      • Nilai, Malaysia
        • Research Site
      • Penang, Malaysia
        • Research Site
  • Mexico
      • Durango, Mexico
        • Research Site
      • Morelia, Mexico
        • Research Site
      • Toluca, Mexico
        • 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
  • Singapore
      • Singapore, Singapore
        • Research Site
  • Spanien
      • A Coruña, Spanien
        • Research Site
      • Alicante, Spanien
        • Research Site
      • Madrid, Spanien
        • Research Site
      • Málaga, Spanien
        • Research Site
      • Zaragoza, Spanien
        • Research Site
  • Thailand
      • Chiang Mai, Thailand
        • Research Site
  • Tyskland
      • Bad Berka, Tyskland
        • Research Site
      • Berlin, Tyskland
        • Research Site
      • Essen, Tyskland
        • Research Site
      • Großhansdorf, Tyskland
        • Research Site
      • Halle, Tyskland
        • Research Site
      • Hamburg, Tyskland
        • Research Site
      • Heidelberg, Tyskland
        • Research Site
      • Köln, Tyskland
        • Research Site
      • Oldenburg, Tyskland
        • Research Site
      • Ulm, Tyskland
        • Research Site
      • Wiesbaden, Tyskland
        • Research Site
  • Vietnam
      • Hanoi city, Vietnam
        • Research Site
      • Ho Chi Minh city, Vietnam
        • Research Site
  • Østrig
      • Graz, Østrig
        • Research Site
      • Grimmenstein, Østrig
        • Research Site
      • Innsbruck, Østrig
        • Research Site
      • Linz, Østrig
        • Research Site
      • Wels, Østrig
        • Research Site
      • Wien, Østrig
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 2
Vandetanib + Docetaxel
Medicin: Docetaxel
infusion
Andre navne:
  • TAXOTERE™
Medicin: Vandetanib
oral
Andre navne:
  • ZD6474
  • ZACTIMA™
Aktiv komparator: 1
Docetaxel monotherapy
Medicin: Docetaxel
infusion
Andre navne:
  • TAXOTERE™

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS) in the Overall Population
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS) in the Overall Population
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genzyme, a Sanofi Company

Efterforskere

  • Studieleder: Contact-US@sanofi.com, Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2006

Primær færdiggørelse (Faktiske)

1. august 2008

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

6. april 2006

Først indsendt, der opfyldte QC-kriterier

6. april 2006

Først opslået (Skøn)

10. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Kliniske forsøg med Docetaxel

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner