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

30 mars 2015 mis à jour par: 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)

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

179

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cabazitaxel
Médicament: 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.
Autres noms:
  • XRP6258
Comparateur actif: Topotécan
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression Free Survival (PFS)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sanofi

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2012

Achèvement primaire (Réel)

1 avril 2014

Achèvement de l'étude (Réel)

1 avril 2014

Dates d'inscription aux études

Première soumission

22 décembre 2011

Première soumission répondant aux critères de contrôle qualité

27 décembre 2011

Première publication (Estimation)

28 décembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

13 avril 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 mars 2015

Dernière vérification

1 mars 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ARD12166
  • 2011-003415-31 (Numéro EudraCT)
  • U1111-1123-3503 (Autre identifiant: UTN)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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