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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 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1690

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Bahía Blanca, Argentinien
        • Research Site
      • Capital Federal, Argentinien
        • Research Site
      • Ciudad de Buenos Aires, Argentinien
        • Research Site
      • Mendoza, Argentinien
        • Research Site
      • Rosario, Argentinien
        • 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
  • China
      • Beijing, China
        • Research Site
      • Chongqing, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Wuhan, China
        • Research Site
  • Deutschland
      • Bad Berka, Deutschland
        • Research Site
      • Berlin, Deutschland
        • Research Site
      • Essen, Deutschland
        • Research Site
      • Großhansdorf, Deutschland
        • Research Site
      • Halle, Deutschland
        • Research Site
      • Hamburg, Deutschland
        • Research Site
      • Heidelberg, Deutschland
        • Research Site
      • Köln, Deutschland
        • Research Site
      • Oldenburg, Deutschland
        • Research Site
      • Ulm, Deutschland
        • Research Site
      • Wiesbaden, Deutschland
        • Research Site
  • Dänemark
      • Herlev, Dänemark
        • Research Site
      • København Ø, Dänemark
        • Research Site
      • Odense, Dänemark
        • Research Site
      • Roskilde, Dänemark
        • Research Site
      • Vejle, Dänemark
        • Research Site
  • Frankreich
      • Bordeaux Cedex, Frankreich
        • Research Site
      • Boulogne Billancourt, Frankreich
        • Research Site
      • Caen Cedex, Frankreich
        • Research Site
      • Dijon, Frankreich
        • Research Site
      • Nancy, Frankreich
        • Research Site
      • Paris, Frankreich
        • Research Site
      • Pierre Benite Cedex, Frankreich
        • Research Site
      • Saint Herblain, Frankreich
        • Research Site
  • Griechenland
      • Athens, Griechenland
        • Research Site
      • Heraklion, Griechenland
        • 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
  • 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
  • Korea, Republik von
      • Seoul, Korea, Republik von
        • Research Site
  • Malaysia
      • Kubang Kerian, Malaysia
        • Research Site
      • Nilai, Malaysia
        • Research Site
      • Penang, Malaysia
        • Research Site
  • Mexiko
      • Durango, Mexiko
        • Research Site
      • Morelia, Mexiko
        • Research Site
      • Toluca, Mexiko
        • Research Site
  • Niederlande
      • Amsterdam, Niederlande
        • Research Site
      • Den Bosch, Niederlande
        • Research Site
      • Groningen, Niederlande
        • Research Site
      • Maastricht, Niederlande
        • 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
  • 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
  • Truthahn
      • Ankara, Truthahn
        • Research Site
      • Istanbul, Truthahn
        • Research Site
      • Izmir, Truthahn
        • Research Site
  • Vereinigte Staaten
    • California
      • Fullerton, California, Vereinigte Staaten
        • Research Site
      • Los Angeles, California, Vereinigte Staaten
        • Research Site
      • Northridge, California, Vereinigte Staaten
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Vereinigte Staaten
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, Vereinigte Staaten
        • Research Site
    • Florida
      • Ocala, Florida, Vereinigte Staaten
        • Research Site
    • Georgia
      • Marietta, Georgia, Vereinigte Staaten
        • Research Site
    • Illinois
      • Joliet, Illinois, Vereinigte Staaten
        • Research Site
      • Park Ridge, Illinois, Vereinigte Staaten
        • Research Site
    • Kansas
      • Hutchinson, Kansas, Vereinigte Staaten
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten
        • Research Site
    • Missouri
      • St. Louis, Missouri, Vereinigte Staaten
        • Research Site
    • Nevada
      • Henderson, Nevada, Vereinigte Staaten
        • Research Site
    • New York
      • Albany, New York, Vereinigte Staaten
        • Research Site
      • Armonk, New York, Vereinigte Staaten
        • Research Site
      • New York, New York, Vereinigte Staaten
        • Research Site
    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten
        • Research Site
      • Hickory, North Carolina, Vereinigte Staaten
        • Research Site
    • Oregon
      • Portland, Oregon, Vereinigte Staaten
        • Research Site
    • Texas
      • Austin, Texas, Vereinigte Staaten
        • Research Site
      • Houston, Texas, Vereinigte Staaten
        • Research Site
    • Utah
      • Ogden, Utah, Vereinigte Staaten
        • Research Site
    • Virginia
      • Alexandria, Virginia, Vereinigte Staaten
        • Research Site
      • Salem, Virginia, Vereinigte Staaten
        • Research Site
    • Washington
      • Vancouver, Washington, Vereinigte Staaten
        • Research Site
  • Vietnam
      • Hanoi city, Vietnam
        • Research Site
      • Ho Chi Minh city, Vietnam
        • Research Site
  • Österreich
      • Graz, Österreich
        • Research Site
      • Grimmenstein, Österreich
        • Research Site
      • Innsbruck, Österreich
        • Research Site
      • Linz, Österreich
        • Research Site
      • Wels, Österreich
        • Research Site
      • Wien, Österreich
        • Research Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 2
Vandetanib + Docetaxel
Arzneimittel: Docetaxel
infusion
Andere Namen:
  • TAXOTERE™
Arzneimittel: Vandetanib
oral
Andere Namen:
  • ZD6474
  • ZACTIMA™
Aktiver Komparator: 1
Docetaxel monotherapy
Arzneimittel: Docetaxel
infusion
Andere Namen:
  • TAXOTERE™

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-Free Survival (PFS) in the Overall Population
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS) in the Overall Population
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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).
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Genzyme, a Sanofi Company

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2006

Primärer Abschluss (Tatsächlich)

1. August 2008

Studienabschluss (Tatsächlich)

1. März 2014

Studienanmeldedaten

Zuerst eingereicht

6. April 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. April 2006

Zuerst gepostet (Schätzen)

10. April 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

30. September 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. August 2016

Zuletzt verifiziert

1. August 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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