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Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

30. März 2015 aktualisiert von: Sanofi

Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

  • To assess disease progression free rate at 12 weeks
  • To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
  • To assess Overall Survival (OS)
  • To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
  • To assess the Health-Related Quality of Life (HRQoL)

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.

All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

179

Phase

  • Phase 2

Kontakte und Standorte

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

Studienorte

  • Brasilien
      • Porto Alegre, Brasilien, 90610-000
        • Investigational Site Number 076001
  • Chile
      • Santiago, Chile, 8380456
        • Investigational Site Number 152001
      • Santiago, Chile
        • Investigational Site Number 152005
  • Deutschland
      • Großhansdorf, Deutschland, 22927
        • Investigational Site Number 276003
      • Löwenstein, Deutschland, 74245
        • Investigational Site Number 276006
  • Frankreich
      • Brest, Frankreich, 29609
        • Investigational Site Number 250005
      • Caen Cedex, Frankreich, 14033
        • Investigational Site Number 250004
      • La Tronche, Frankreich, 38700
        • Investigational Site Number 250006
      • Lille, Frankreich, 59800
        • Investigational Site Number 250002
      • Saint-Herblain Cedex, Frankreich, 44805
        • Investigational Site Number 250003
      • Villejuif Cedex, Frankreich, 94805
        • Investigational Site Number 250007
  • Griechenland
      • Athens, Griechenland, 11522
        • Investigational Site Number 300005
      • Athens, Griechenland, 11527
        • Investigational Site Number 300003
      • Heraklion, Griechenland, 71110
        • Investigational Site Number 300001
      • Thessaloniki, Griechenland, 54629
        • Investigational Site Number 300002
      • Thessaloniki, Griechenland, 57010
        • Investigational Site Number 300004
  • Italien
      • Genova, Italien, 16132
        • Investigational Site Number 380001
      • Livorno, Italien, 57123
        • Investigational Site Number 380002
      • Novara, Italien, 28100
        • Investigational Site Number 380005
      • Parma, Italien, 43100
        • Investigational Site Number 380004
  • Kanada
      • Montreal, Kanada, H3T 1E2
        • Investigational Site Number 124003
      • Oshawa, Kanada, L1G 2B9
        • Investigational Site Number 124002
      • Rimouski, Kanada, G5L 5T1
        • Investigational Site Number 124004
      • Toronto, Kanada, M5G 2M9
        • Investigational Site Number 124001
  • Korea, Republik von
      • Seoul, Korea, Republik von, 120-752
        • Investigational Site Number 410001
      • Seoul, Korea, Republik von, 135-710
        • Investigational Site Number 410003
      • Seoul, Korea, Republik von, 138-736
        • Investigational Site Number 410002
  • Norwegen
      • Oslo, Norwegen, 0440
        • Investigational Site Number 578001
      • Stavanger, Norwegen, 4011
        • Investigational Site Number 578003
      • Trondheim, Norwegen, 7006
        • Investigational Site Number 578002
  • Polen
      • Gdansk, Polen, 80-952
        • Investigational Site Number 616004
      • Lublin, Polen, 20-954
        • Investigational Site Number 616003
      • Poznan, Polen, 60-569
        • Investigational Site Number 616002
      • Warszawa, Polen, 02-781
        • Investigational Site Number 616001
  • Rumänien
      • Cluj Napoca, Rumänien, 400015
        • Investigational Site Number 642003
      • Cluj-Napoca, Rumänien, 400015
        • Investigational Site Number 642005
      • Craiova, Rumänien, 200385
        • Investigational Site Number 642001
      • Timisoara, Rumänien
        • Investigational Site Number 642002
  • Russische Föderation
      • Moscow, Russische Föderation, 115478
        • Investigational Site Number 643001
      • St-Petersburg, Russische Föderation, 197758
        • Investigational Site Number 643005
      • Tula, Russische Föderation, 300053
        • Investigational Site Number 643006
      • Yaroslavl, Russische Föderation, 150054
        • Investigational Site Number 643003
  • Spanien
      • Badalona, Spanien, 08916
        • Investigational Site Number 724002
      • Barcelona, Spanien, 08035
        • Investigational Site Number 724004
      • Málaga, Spanien, 29010
        • Investigational Site Number 724005
      • Valencia, Spanien, 46026
        • Investigational Site Number 724001
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Investigational Site Number 804002
      • Donetsk, Ukraine, 83092
        • Investigational Site Number 804004
      • Lviv, Ukraine, 70031
        • Investigational Site Number 804001
  • Ungarn
      • Budapest, Ungarn, 1121
        • Investigational Site Number 348001
      • Budapest, Ungarn, 1121
        • Investigational Site Number 348004
      • Budapest, Ungarn, 1125
        • Investigational Site Number 348002
      • Törökbálint, Ungarn, 2045
        • Investigational Site Number 348003
  • Vereinigte Staaten
    • Alabama
      • Muscle Shoals, Alabama, Vereinigte Staaten, 35661
        • Investigational Site Number 840007
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68114
        • Investigational Site Number 840005
    • New Hampshire
      • Lebanon, New Hampshire, Vereinigte Staaten, 03756
        • Investigational Site Number 840006
    • Ohio
      • Middletown, Ohio, Vereinigte Staaten, 45042
        • Investigational Site Number 840003
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Investigational Site Number 840001

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 :

  • Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy
  • Male or female greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)
  • Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1

Exclusion criteria:

  • Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study
  • More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes
  • Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)
  • Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization
  • Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included
  • Participants with known leptomeningeal metastases
  • History of other, invasive neoplasm requiring ongoing therapy
  • Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack
  • Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results
  • Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)
  • Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
  • Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation
  • History of hypersensitivity to polysorbate 80

  • Inadequate organ and bone marrow function as evidenced by:

    • Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)
    • Absolute neutrophil count <1.5 x 10^9 per liter
    • Platelet count <100 x 10^9 per liter
    • Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)
    • Alkaline Phosphatase (AP) >2.5 x ULN. In case of liver metastases AP >5 x ULN
    • Total bilirubin >1.0 x ULN
    • Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cabazitaxel
Arzneimittel: Cabazitaxel
Cabazitaxel 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Andere Namen:
  • XRP6258
Aktiver Komparator: Topotecan
Arzneimittel: Topotecan
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression Free Survival (PFS)
Zeitfenster: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival
Zeitfenster: From randomization to date of death (maximum 15 months)
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.
From randomization to date of death (maximum 15 months)
Progression Free Rate at Week 12
Zeitfenster: Week 12
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.
Week 12
Overall Objective Tumor Response Rate
Zeitfenster: Randomization to disease progression/occurrence (maximum 7.6 months)
Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.
Randomization to disease progression/occurrence (maximum 7.6 months)

Mitarbeiter und Ermittler

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

Sponsor

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

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. März 2012

Primärer Abschluss (Tatsächlich)

1. April 2014

Studienabschluss (Tatsächlich)

1. April 2014

Studienanmeldedaten

Zuerst eingereicht

22. Dezember 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Dezember 2011

Zuerst gepostet (Schätzen)

28. Dezember 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

13. April 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. März 2015

Zuletzt verifiziert

1. März 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ARD12166
  • 2011-003415-31 (EudraCT-Nummer)
  • U1111-1123-3503 (Andere Kennung: UTN)

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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