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

30 de marzo de 2015 actualizado por: 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)

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

179

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Großhansdorf, Alemania, 22927
        • Investigational Site Number 276003
      • Löwenstein, Alemania, 74245
        • Investigational Site Number 276006
  • Brasil
      • Porto Alegre, Brasil, 90610-000
        • Investigational Site Number 076001
  • Canadá
      • Montreal, Canadá, H3T 1E2
        • Investigational Site Number 124003
      • Oshawa, Canadá, L1G 2B9
        • Investigational Site Number 124002
      • Rimouski, Canadá, G5L 5T1
        • Investigational Site Number 124004
      • Toronto, Canadá, M5G 2M9
        • Investigational Site Number 124001
  • Chile
      • Santiago, Chile, 8380456
        • Investigational Site Number 152001
      • Santiago, Chile
        • Investigational Site Number 152005
  • Corea, república de
      • Seoul, Corea, república de, 120-752
        • Investigational Site Number 410001
      • Seoul, Corea, república de, 135-710
        • Investigational Site Number 410003
      • Seoul, Corea, república de, 138-736
        • Investigational Site Number 410002
  • España
      • Badalona, España, 08916
        • Investigational Site Number 724002
      • Barcelona, España, 08035
        • Investigational Site Number 724004
      • Málaga, España, 29010
        • Investigational Site Number 724005
      • Valencia, España, 46026
        • Investigational Site Number 724001
  • Estados Unidos
    • Alabama
      • Muscle Shoals, Alabama, Estados Unidos, 35661
        • Investigational Site Number 840007
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68114
        • Investigational Site Number 840005
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Investigational Site Number 840006
    • Ohio
      • Middletown, Ohio, Estados Unidos, 45042
        • Investigational Site Number 840003
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Investigational Site Number 840001
  • Federación Rusa
      • Moscow, Federación Rusa, 115478
        • Investigational Site Number 643001
      • St-Petersburg, Federación Rusa, 197758
        • Investigational Site Number 643005
      • Tula, Federación Rusa, 300053
        • Investigational Site Number 643006
      • Yaroslavl, Federación Rusa, 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
  • 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
  • Hungría
      • Budapest, Hungría, 1121
        • Investigational Site Number 348001
      • Budapest, Hungría, 1121
        • Investigational Site Number 348004
      • Budapest, Hungría, 1125
        • Investigational Site Number 348002
      • Törökbálint, Hungría, 2045
        • Investigational Site Number 348003
  • 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
  • Noruega
      • Oslo, Noruega, 0440
        • Investigational Site Number 578001
      • Stavanger, Noruega, 4011
        • Investigational Site Number 578003
      • Trondheim, Noruega, 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
  • Rumania
      • Cluj Napoca, Rumania, 400015
        • Investigational Site Number 642003
      • Cluj-Napoca, Rumania, 400015
        • Investigational Site Number 642005
      • Craiova, Rumania, 200385
        • Investigational Site Number 642001
      • Timisoara, Rumania
        • Investigational Site Number 642002
  • Ucrania
      • Dnipropetrovsk, Ucrania, 49102
        • Investigational Site Number 804002
      • Donetsk, Ucrania, 83092
        • Investigational Site Number 804004
      • Lviv, Ucrania, 70031
        • Investigational Site Number 804001

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otros nombres:
  • XRP6258
Comparador activo: Topotecán
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression Free Survival (PFS)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2012

Finalización primaria (Actual)

1 de abril de 2014

Finalización del estudio (Actual)

1 de abril de 2014

Fechas de registro del estudio

Enviado por primera vez

22 de diciembre de 2011

Primero enviado que cumplió con los criterios de control de calidad

27 de diciembre de 2011

Publicado por primera vez (Estimar)

28 de diciembre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de abril de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

30 de marzo de 2015

Última verificación

1 de marzo de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ARD12166
  • 2011-003415-31 (Número EudraCT)
  • U1111-1123-3503 (Otro identificador: UTN)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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