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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. srpna 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

1690

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • 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
  • Belgie
      • Brussels (Jette), Belgie
        • Research Site
      • Brussels (Woluwé-St-Lambert), Belgie
        • Research Site
      • Edegem, Belgie
        • Research Site
      • Genk, Belgie
        • Research Site
      • Liege, Belgie
        • Research Site
  • Brazílie
      • Fortaleza, Brazílie
        • Research Site
      • Goiânia, Brazílie
        • Research Site
      • Porto Alegre, Brazílie
        • Research Site
      • Rio de Janeiro, Brazílie
        • Research Site
      • Sao Paulo, Brazílie
        • Research Site
  • Dánsko
      • Herlev, Dánsko
        • Research Site
      • København Ø, Dánsko
        • Research Site
      • Odense, Dánsko
        • Research Site
      • Roskilde, Dánsko
        • Research Site
      • Vejle, Dánsko
        • Research Site
  • Francie
      • Bordeaux Cedex, Francie
        • Research Site
      • Boulogne Billancourt, Francie
        • Research Site
      • Caen Cedex, Francie
        • Research Site
      • Dijon, Francie
        • Research Site
      • Nancy, Francie
        • Research Site
      • Paris, Francie
        • Research Site
      • Pierre Benite Cedex, Francie
        • Research Site
      • Saint Herblain, Francie
        • Research Site
  • Holandsko
      • Amsterdam, Holandsko
        • Research Site
      • Den Bosch, Holandsko
        • Research Site
      • Groningen, Holandsko
        • Research Site
      • Maastricht, Holandsko
        • Research Site
  • Indie
      • Ahmedabad, Indie
        • Research Site
      • Chennai, Indie
        • Research Site
      • Hyderabad, Indie
        • Research Site
      • Kolkata, Indie
        • Research Site
      • New Delhi, Indie
        • Research Site
      • Pune, Indie
        • Research Site
      • Vellore, Indie
        • Research Site
  • Indonésie
      • Jakarta Timur, Indonésie
        • Research Site
      • Yogyakarta, Indonésie
        • Research Site
  • Itálie
      • Ancona, Itálie
        • Research Site
      • Avellino, Itálie
        • Research Site
      • Bologna, Itálie
        • Research Site
      • Genova, Itálie
        • Research Site
      • Mantova, Itálie
        • Research Site
      • Napoli, Itálie
        • Research Site
      • Orbassano, Itálie
        • Research Site
      • Parma, Itálie
        • Research Site
      • Perugia, Itálie
        • Research Site
      • Pisa, Itálie
        • Research Site
      • Reggio Emilia, Itálie
        • Research Site
  • Japonsko
      • Akashi-shi, Japonsko
        • Research Site
      • Fukuoka, Japonsko
        • Research Site
      • Fukuoka-shi, Japonsko
        • Research Site
      • Isehara-shi, Japonsko
        • Research Site
      • Kobe-shi, Japonsko
        • Research Site
      • Koto-ku, Japonsko
        • Research Site
      • Kumamoto-shi, Japonsko
        • Research Site
      • Matsuyama-shi, Japonsko
        • Research Site
      • Nagoya-shi, Japonsko
        • Research Site
      • Okayama-shi, Japonsko
        • Research Site
      • Okazaki-shi, Japonsko
        • Research Site
      • Osaka-shi, Japonsko
        • Research Site
      • Osakasayama-shi, Japonsko
        • Research Site
      • Sakai-shi, Japonsko
        • Research Site
      • Sapporo-shi, Japonsko
        • Research Site
      • Shinjuku-ku, Japonsko
        • Research Site
      • Sunto-gun, Japonsko
        • Research Site
      • Toyonaka, Japonsko
        • Research Site
      • Ube-shi, Japonsko
        • Research Site
      • Utsunomiya-shi, Japonsko
        • Research Site
      • Yokohama-shi, Japonsko
        • Research Site
  • Kanada
      • Quebec, Kanada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Kanada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Kanada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada
        • Research Site
    • Ontario
      • Kitchener, Ontario, Kanada
        • Research Site
      • London, Ontario, Kanada
        • Research Site
      • Toronto, Ontario, Kanada
        • Research Site
    • Quebec
      • Laval, Quebec, Kanada
        • Research Site
  • Korejská republika
      • Seoul, Korejská republika
        • Research Site
  • Krocan
      • Ankara, Krocan
        • Research Site
      • Istanbul, Krocan
        • Research Site
      • Izmir, Krocan
        • Research Site
  • Malajsie
      • Kubang Kerian, Malajsie
        • Research Site
      • Nilai, Malajsie
        • Research Site
      • Penang, Malajsie
        • Research Site
  • Mexiko
      • Durango, Mexiko
        • Research Site
      • Morelia, Mexiko
        • Research Site
      • Toluca, Mexiko
        • Research Site
  • Německo
      • Bad Berka, Německo
        • Research Site
      • Berlin, Německo
        • Research Site
      • Essen, Německo
        • Research Site
      • Großhansdorf, Německo
        • Research Site
      • Halle, Německo
        • Research Site
      • Hamburg, Německo
        • Research Site
      • Heidelberg, Německo
        • Research Site
      • Köln, Německo
        • Research Site
      • Oldenburg, Německo
        • Research Site
      • Ulm, Německo
        • Research Site
      • Wiesbaden, Německo
        • Research Site
  • Portugalsko
      • Coimbra, Portugalsko
        • Research Site
      • Funchal, Portugalsko
        • Research Site
      • Lisboa, Portugalsko
        • Research Site
      • Porto, Portugalsko
        • Research Site
      • Vila Nova de Gaia, Portugalsko
        • Research Site
  • Rakousko
      • Graz, Rakousko
        • Research Site
      • Grimmenstein, Rakousko
        • Research Site
      • Innsbruck, Rakousko
        • Research Site
      • Linz, Rakousko
        • Research Site
      • Wels, Rakousko
        • Research Site
      • Wien, Rakousko
        • Research Site
  • Singapur
      • Singapore, Singapur
        • Research Site
  • Spojené státy
    • California
      • Fullerton, California, Spojené státy
        • Research Site
      • Los Angeles, California, Spojené státy
        • Research Site
      • Northridge, California, Spojené státy
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Spojené státy
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, Spojené státy
        • Research Site
    • Florida
      • Ocala, Florida, Spojené státy
        • Research Site
    • Georgia
      • Marietta, Georgia, Spojené státy
        • Research Site
    • Illinois
      • Joliet, Illinois, Spojené státy
        • Research Site
      • Park Ridge, Illinois, Spojené státy
        • Research Site
    • Kansas
      • Hutchinson, Kansas, Spojené státy
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Spojené státy
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Spojené státy
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Spojené státy
        • Research Site
    • Missouri
      • St. Louis, Missouri, Spojené státy
        • Research Site
    • Nevada
      • Henderson, Nevada, Spojené státy
        • Research Site
    • New York
      • Albany, New York, Spojené státy
        • Research Site
      • Armonk, New York, Spojené státy
        • Research Site
      • New York, New York, Spojené státy
        • Research Site
    • North Carolina
      • Durham, North Carolina, Spojené státy
        • Research Site
      • Hickory, North Carolina, Spojené státy
        • Research Site
    • Oregon
      • Portland, Oregon, Spojené státy
        • Research Site
    • Texas
      • Austin, Texas, Spojené státy
        • Research Site
      • Houston, Texas, Spojené státy
        • Research Site
    • Utah
      • Ogden, Utah, Spojené státy
        • Research Site
    • Virginia
      • Alexandria, Virginia, Spojené státy
        • Research Site
      • Salem, Virginia, Spojené státy
        • Research Site
    • Washington
      • Vancouver, Washington, Spojené státy
        • Research Site
  • Thajsko
      • Chiang Mai, Thajsko
        • Research Site
  • Vietnam
      • Hanoi city, Vietnam
        • Research Site
      • Ho Chi Minh city, Vietnam
        • Research Site
  • Čína
      • Beijing, Čína
        • Research Site
      • Chongqing, Čína
        • Research Site
      • Guangzhou, Čína
        • Research Site
      • Nanjing, Čína
        • Research Site
      • Shanghai, Čína
        • Research Site
      • Wuhan, Čína
        • Research Site
  • Řecko
      • Athens, Řecko
        • Research Site
      • Heraklion, Řecko
        • Research Site
  • Španělsko
      • A Coruña, Španělsko
        • Research Site
      • Alicante, Španělsko
        • Research Site
      • Madrid, Španělsko
        • Research Site
      • Málaga, Španělsko
        • Research Site
      • Zaragoza, Španělsko
        • Research Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 2
Vandetanib + docetaxel
Lék: Docetaxel
infusion
Ostatní jména:
  • TAXOTERE™
Lék: Vandetanib
oral
Ostatní jména:
  • ZD6474
  • ZACTIMA™
Aktivní komparátor: 1
Docetaxel monotherapy
Lék: Docetaxel
infusion
Ostatní jména:
  • TAXOTERE™

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-Free Survival (PFS) in the Overall Population
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival (OS) in the Overall Population
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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).
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Genzyme, a Sanofi Company

Vyšetřovatelé

  • Ředitel studie: Contact-US@sanofi.com, Sanofi

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2006

Primární dokončení (Aktuální)

1. srpna 2008

Dokončení studie (Aktuální)

1. března 2014

Termíny zápisu do studia

První předloženo

6. dubna 2006

První předloženo, které splnilo kritéria kontroly kvality

6. dubna 2006

První zveřejněno (Odhad)

10. dubna 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

30. září 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. srpna 2016

Naposledy ověřeno

1. srpna 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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