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

30 marzo 2015 aggiornato da: 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)

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

179

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Brasile
      • Porto Alegre, Brasile, 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
  • Chile
      • Santiago, Chile, 8380456
        • Investigational Site Number 152001
      • Santiago, Chile
        • Investigational Site Number 152005
  • Corea, Repubblica di
      • Seoul, Corea, Repubblica di, 120-752
        • Investigational Site Number 410001
      • Seoul, Corea, Repubblica di, 135-710
        • Investigational Site Number 410003
      • Seoul, Corea, Repubblica di, 138-736
        • Investigational Site Number 410002
  • Federazione Russa
      • Moscow, Federazione Russa, 115478
        • Investigational Site Number 643001
      • St-Petersburg, Federazione Russa, 197758
        • Investigational Site Number 643005
      • Tula, Federazione Russa, 300053
        • Investigational Site Number 643006
      • Yaroslavl, Federazione Russa, 150054
        • Investigational Site Number 643003
  • Francia
      • Brest, Francia, 29609
        • Investigational Site Number 250005
      • Caen Cedex, Francia, 14033
        • Investigational Site Number 250004
      • La Tronche, Francia, 38700
        • Investigational Site Number 250006
      • Lille, Francia, 59800
        • Investigational Site Number 250002
      • Saint-Herblain Cedex, Francia, 44805
        • Investigational Site Number 250003
      • Villejuif Cedex, Francia, 94805
        • Investigational Site Number 250007
  • Germania
      • Großhansdorf, Germania, 22927
        • Investigational Site Number 276003
      • Löwenstein, Germania, 74245
        • Investigational Site Number 276006
  • Grecia
      • Athens, Grecia, 11522
        • Investigational Site Number 300005
      • Athens, Grecia, 11527
        • Investigational Site Number 300003
      • Heraklion, Grecia, 71110
        • Investigational Site Number 300001
      • Thessaloniki, Grecia, 54629
        • Investigational Site Number 300002
      • Thessaloniki, Grecia, 57010
        • Investigational Site Number 300004
  • Italia
      • Genova, Italia, 16132
        • Investigational Site Number 380001
      • Livorno, Italia, 57123
        • Investigational Site Number 380002
      • Novara, Italia, 28100
        • Investigational Site Number 380005
      • Parma, Italia, 43100
        • Investigational Site Number 380004
  • Norvegia
      • Oslo, Norvegia, 0440
        • Investigational Site Number 578001
      • Stavanger, Norvegia, 4011
        • Investigational Site Number 578003
      • Trondheim, Norvegia, 7006
        • Investigational Site Number 578002
  • Polonia
      • Gdansk, Polonia, 80-952
        • Investigational Site Number 616004
      • Lublin, Polonia, 20-954
        • Investigational Site Number 616003
      • Poznan, Polonia, 60-569
        • Investigational Site Number 616002
      • Warszawa, Polonia, 02-781
        • Investigational Site Number 616001
  • Romania
      • Cluj Napoca, Romania, 400015
        • Investigational Site Number 642003
      • Cluj-Napoca, Romania, 400015
        • Investigational Site Number 642005
      • Craiova, Romania, 200385
        • Investigational Site Number 642001
      • Timisoara, Romania
        • Investigational Site Number 642002
  • Spagna
      • Badalona, Spagna, 08916
        • Investigational Site Number 724002
      • Barcelona, Spagna, 08035
        • Investigational Site Number 724004
      • Málaga, Spagna, 29010
        • Investigational Site Number 724005
      • Valencia, Spagna, 46026
        • Investigational Site Number 724001
  • Stati Uniti
    • Alabama
      • Muscle Shoals, Alabama, Stati Uniti, 35661
        • Investigational Site Number 840007
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68114
        • Investigational Site Number 840005
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Investigational Site Number 840006
    • Ohio
      • Middletown, Ohio, Stati Uniti, 45042
        • Investigational Site Number 840003
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Investigational Site Number 840001
  • Ucraina
      • Dnipropetrovsk, Ucraina, 49102
        • Investigational Site Number 804002
      • Donetsk, Ucraina, 83092
        • Investigational Site Number 804004
      • Lviv, Ucraina, 70031
        • Investigational Site Number 804001
  • Ungheria
      • Budapest, Ungheria, 1121
        • Investigational Site Number 348001
      • Budapest, Ungheria, 1121
        • Investigational Site Number 348004
      • Budapest, Ungheria, 1125
        • Investigational Site Number 348002
      • Törökbálint, Ungheria, 2045
        • Investigational Site Number 348003

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cabazitaxel
Droga: 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.
Altri nomi:
  • XRP6258
Comparatore attivo: Topotecan
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sanofi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2012

Completamento primario (Effettivo)

1 aprile 2014

Completamento dello studio (Effettivo)

1 aprile 2014

Date di iscrizione allo studio

Primo inviato

22 dicembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

27 dicembre 2011

Primo Inserito (Stima)

28 dicembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

13 aprile 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 marzo 2015

Ultimo verificato

1 marzo 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ARD12166
  • 2011-003415-31 (Numero EudraCT)
  • U1111-1123-3503 (Altro identificatore: UTN)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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