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Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

24 de noviembre de 2015 actualizado por: Eli Lilly and Company

Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

72

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

    • New Brunswick
      • Moncton, New Brunswick, Canadá, E1C 6Z8
        • The Moncton Hospital
    • Newfoundland and Labrador
      • Grand Falls-Windsor, Newfoundland and Labrador, Canadá, A2A 2E2
        • Local Institution
    • Ontario
      • Mississauga, Ontario, Canadá, L5M 2N1
        • The Credit Valley Hospital
      • Sudbury, Ontario, Canadá, P3E 5J1
        • Sudbury Regional Hospital
      • Thunder Bay, Ontario, Canadá, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre (Regional Cancer Care)
      • Toronto, Ontario, Canadá, M4C 3E7
        • Toronto East General Hospital
    • Quebec
      • Rimouski, Quebec, Canadá, G5L 5T1
        • Centre De Sante Et De Services Sociaux De Rimouski-Neigette
    • Arizona
      • Casa Grande, Arizona, Estados Unidos, 85122
        • Donald W. Hill M.D., P.C.
    • California
      • Beverly Hills, California, Estados Unidos, 90211
        • Beverly Hills Cancer Center
      • Los Angeles, California, Estados Unidos, 90036
        • Cancer Care Institute
      • Oakland, California, Estados Unidos, 94609
        • Northern California Hematology & Oncology
      • San Diego, California, Estados Unidos, 92123
        • Sharp Clinical Oncology Research
    • Florida
      • Ft. Lauderdale, Florida, Estados Unidos, 33308
        • Broward Oncology Associates, P.A.
      • Miami, Florida, Estados Unidos, 33125
        • Elite Research Institute
    • Illinois
      • Skokie, Illinois, Estados Unidos, 60076
        • Edward H. Kaplan, MD & Associates
    • Minnesota
      • Edina, Minnesota, Estados Unidos, 55435
        • Fairview Southdale Medical Oncology Clinic
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Mid Dakota Clinic, PC
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19140
        • Temple University Hospital
    • Texas
      • Lubbock, Texas, Estados Unidos, 79415
        • University Medical Center
    • Washington
      • Kennewick, Washington, Estados Unidos, 99336
        • Columbia Basin Hematology and Oncology
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine (Caimed Center)
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego

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:

  • Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
  • Evaluable or measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

  • Uncontrolled Central Nervous System (CNS) metastasis.
  • Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
  • Concurrent malignancy
  • Prior chemotherapy for NSCLC
  • Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
  • Superior vena cava syndrome contra-indicating hydration
  • White Blood Cells (WBC) < 3,000/mm³
  • Absolute neutrophile count (ANC) < 1,500/mm³
  • Platelet < 100,000/mm³
  • Hemoglobin (Hgb) < 9.0 g/dL
  • Total bilirubin > 1.5 x Upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) > 5.0 x ULN.
  • Serum creatinine >1.25 x ULN and calculated creatinine clearance <60mL/min

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cetuximab + Cisplatin + Vinorelbine
Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
Otros nombres:
  • Erbitux
  • BMS-564717
Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
Otros nombres:
  • Platinol
Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
Otros nombres:
  • Navelbine

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Periodo de tiempo: Day 1 up to 30 days after last dose
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Day 1 up to 30 days after last dose
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Periodo de tiempo: Day 1 to 30 days after last dose
Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0). Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Day 1 to 30 days after last dose
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
Periodo de tiempo: Day 1 up to 30 days after last dose
ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN - 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN - 1.5*ULN; Grade 2: >1.5 - 3.0*ULN; Grade 3: >3.0 - 10.0*ULN; Grade 4: >10.0*ULN. Albumin (low) Grade 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Grade 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Grade 3: < 2 g/dL to <2 g/L. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Day 1 up to 30 days after last dose
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
Periodo de tiempo: Day 2 up to 30 days after last dose
Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug. WBC normal range: 4.1-12.3 x 10^3 /microliter (µL); platelets normal range: 140-450 x 10^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36 x 10^9/μL.
Day 2 up to 30 days after last dose
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Periodo de tiempo: Day 1 up to 30 days after last dose
ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal. CTC grade criteria: Sodium high (H) Grade (Gr) 1:>ULN - 150 millimoles per liter (mmol/L); Gr 2: >150 - 155 mmol/L; Gr 3: >155 - 160mmol/L; Gr 4: >160 mmol/L. Sodium low(L) Gr 1:<LLN - 130mmol/L; Gr 3: <130 - 120 mmol/L; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN - 5.5 mmol/L; Gr 2: >5.5 - 6.0 mmol/L; Gr 3: > 6.0 - 7.0 mmol/L; Gr 4: >7.0 mmol/L. Potassium (L) Gr 1: <LLN - 3.0 mmol/L; Gr 2: <LLN - 3.0 mmol/L; Gr 3: < 3.0 - 2.5 mmol/L; Gr 4: <2.5 mmol/L. Serum creatinine (H) Gr 1: >1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.
Day 1 up to 30 days after last dose
Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Periodo de tiempo: Day 1 up to 30 days after last dose
Drug-related AEs and drug-related SAEs (by investigator assessment) were those with a relationship to study drug(s) reported to Sponsor as related and those of unknown relationship. AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE was defined as a medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.
Day 1 up to 30 days after last dose
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
Periodo de tiempo: Day 1 up to 30 days after last dose
Drug-related AEs (investigator assessment): those with relationship to study drug(s)reported as related and those of unknown relationship. Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several MedDRA terms (MedDRA version 14.0). Except for Gr 3 and 4 infusion reactions, AE severity per NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Gr 3 - 4 infusion reactions: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=life-threatening event with same Gr 3 symptomatology, complicated by symptomatic hypotension/oxygen saturation 70% or less. Day 1=start of study drug; to 30 days after last dose of any treatment.
Day 1 up to 30 days after last dose

Colaboradores e Investigadores

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

Patrocinador

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 julio de 2010

Finalización primaria (Actual)

1 de septiembre de 2012

Finalización del estudio (Actual)

1 de septiembre de 2012

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2010

Primero enviado que cumplió con los criterios de control de calidad

22 de abril de 2010

Publicado por primera vez (Estimar)

23 de abril de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de diciembre de 2015

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

24 de noviembre de 2015

Última verificación

1 de noviembre de 2015

Más información

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. .

Ensayos clínicos sobre Cetuximab

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