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A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer

18 de enero de 2013 actualizado por: Pfizer

A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Cancer

This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Tipo de estudio

Intervencionista

Inscripción (Actual)

9

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

  • Canadá
    • Ontario
      • Oshawa, Ontario, Canadá, L1G 2B9
        • Pfizer Investigational Site
      • Sudbury, Ontario, Canadá, P3E 5J1
        • Pfizer Investigational Site
    • Quebec
      • Levis, Quebec, Canadá, G6V 3Z1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canadá, H4J 1C5
        • Pfizer Investigational Site
  • España
      • Barcelona, España, 08036
        • Pfizer Investigational Site
      • Barcelona, España, 08025
        • Pfizer Investigational Site
      • Las Palmas de Gran Canaria, España, 35016
        • Pfizer Investigational Site
      • Madrid, España, 28041
        • Pfizer Investigational Site
      • Malaga, España, 29010
        • Pfizer Investigational Site
      • Sevilla, España, 41013
        • Pfizer Investigational Site
      • Sevilla, España, 41009
        • Pfizer Investigational Site
      • Valencia, España, 46026
        • Pfizer Investigational Site
  • Estados Unidos
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20007-2197
        • Pfizer Investigational Site
      • Washington, District of Columbia, Estados Unidos, 20007
        • Pfizer Investigational Site
    • Louisiana
      • Marrero, Louisiana, Estados Unidos, 70072
        • Pfizer Investigational Site
      • Metairie, Louisiana, Estados Unidos, 70006
        • Pfizer Investigational Site
    • Missouri
      • Creve Coeur, Missouri, Estados Unidos, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, Estados Unidos, 63110
        • Pfizer Investigational Site
      • St. Louis, Missouri, Estados Unidos, 63110-1094
        • Pfizer Investigational Site
      • St. Peters, Missouri, Estados Unidos, 63376
        • Pfizer Investigational Site
    • New Jersey
      • Morristown, New Jersey, Estados Unidos, 07962
        • Pfizer Investigational Site
    • North Carolina
      • Hickory, North Carolina, Estados Unidos, 28602
        • Pfizer Investigational Site
      • Kernersville, North Carolina, Estados Unidos, 27284
        • Pfizer Investigational Site
      • Lenoir, North Carolina, Estados Unidos, 28645
        • Pfizer Investigational Site
      • Lexington, North Carolina, Estados Unidos, 27295
        • Pfizer Investigational Site
      • Mount Airy, North Carolina, Estados Unidos, 27030
        • Pfizer Investigational Site
      • North Wilkesboro, North Carolina, Estados Unidos, 28659
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • Pfizer Investigational Site
    • Oregon
      • Beaverton, Oregon, Estados Unidos, 97006
        • Pfizer Investigational Site
      • Gresham, Oregon, Estados Unidos, 97030
        • Pfizer Investigational Site
      • Portland, Oregon, Estados Unidos, 97210
        • Pfizer Investigational Site
      • Portland, Oregon, Estados Unidos, 97239
        • Pfizer Investigational Site
      • Tualatin, Oregon, Estados Unidos, 97062
        • Pfizer Investigational Site
    • Pennsylvania
      • West Reading, Pennsylvania, Estados Unidos, 19611
        • Pfizer Investigational Site
    • Virginia
      • Christiansburg, Virginia, Estados Unidos, 24074
        • Pfizer Investigational Site
      • Low Moor, Virginia, Estados Unidos, 24457
        • Pfizer Investigational Site
      • Roanoke, Virginia, Estados Unidos, 24014
        • Pfizer Investigational Site
      • Salem, Virginia, Estados Unidos, 24153
        • Pfizer Investigational Site
      • Wytheville, Virginia, Estados Unidos, 24382
        • Pfizer Investigational Site
    • Washington
      • Everett, Washington, Estados Unidos, 98201
        • Pfizer Investigational Site
      • Federal Way, Washington, Estados Unidos, 98003
        • Pfizer Investigational Site
      • Gig Harbor, Washington, Estados Unidos, 98332
        • Pfizer Investigational Site
      • Kennewick, Washington, Estados Unidos, 99336
        • Pfizer Investigational Site
      • Lakewood, Washington, Estados Unidos, 98499
        • Pfizer Investigational Site
      • Puyallup, Washington, Estados Unidos, 98372
        • Pfizer Investigational Site
      • Tacoma, Washington, Estados Unidos, 98405
        • Pfizer Investigational Site
  • Hungría
      • Budapest, Hungría, 1125
        • Pfizer Investigational Site
      • Debrecen, Hungría, 4032
        • Pfizer Investigational Site
      • Deszk, Hungría, 6772
        • Pfizer Investigational Site
      • Farkasgyepu, Hungría, 8582
        • Pfizer Investigational Site
      • Torokbalint, Hungría, 2045
        • Pfizer Investigational Site

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:

  • Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer (SCLC), with tumor biopsy sample required.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 > or = 120 ng/ml

Exclusion Criteria:

  • Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
  • HbA1c > or = 5.7%

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: Arm A
Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
Droga: figitumumab
Figitumumab (20 mg/kg)
Droga: Cisplatin (Or Carboplatin)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Droga: Etoposide
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Comparador activo: Arm B
Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
Droga: Cisplatin (Or Carboplatin)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Droga: Etoposide
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS)
Periodo de tiempo: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].
Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Objective Response
Periodo de tiempo: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.
Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Overall Survival (OS)
Periodo de tiempo: Every 3 months until death or 12 months from the date the last participant was randomized
Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].
Every 3 months until death or 12 months from the date the last participant was randomized
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline up to follow-up (90 days post dose)
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.
Baseline up to follow-up (90 days post dose)
Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Periodo de tiempo: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab
Periodo de tiempo: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide
Periodo de tiempo: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Maximum Observed Plasma Concentration (Cmax) of Etoposide
Periodo de tiempo: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
Periodo de tiempo: Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab
Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose
Cancer Dyspnea Scale (CDS) Score
Periodo de tiempo: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 "Not at All" to 5 "Very Much").
Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
Numeric Rating Scale (NRS) Score
Periodo de tiempo: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess "worst pain" severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain.
Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway
Periodo de tiempo: Baseline prior to dosing
Baseline prior to dosing
Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers
Periodo de tiempo: Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs
Periodo de tiempo: Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)
Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs
Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)

Colaboradores e Investigadores

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

Patrocinador

Pfizer

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.

Enlaces Útiles

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 abril de 2010

Finalización primaria (Actual)

1 de octubre de 2011

Finalización del estudio (Actual)

1 de octubre de 2011

Fechas de registro del estudio

Enviado por primera vez

10 de septiembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2009

Publicado por primera vez (Estimar)

15 de septiembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

25 de febrero de 2013

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

18 de enero de 2013

Última verificación

1 de enero de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A4021032

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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