- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00234052
Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin, pemetrexed disodium, and bevacizumab.
Secondary
- Determine the response rate and duration of response in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with complete response, partial response, or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Illinois
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Chicago, Illinois, Estados Unidos, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, Estados Unidos, 60612
- Rush Cancer Institute at Rush University Medical Center
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Evanston, Illinois, Estados Unidos, 60201-1781
- Evanston Northwestern Healthcare - Evanston Hospital
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Harvey, Illinois, Estados Unidos, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Park Ridge, Illinois, Estados Unidos, 60068-1174
- Advocate Lutheran General Cancer Care Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically* or cytologically* confirmed non-small cell lung cancer
Any histology, except squamous cell carcinoma, allowed
- Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible
- No histology in close proximity to a major vessel or cavitation NOTE: *Histologic or cytologic elements may be established on metastatic tumor aspirates or biopsy
Meets 1 of the following stage criteria:
- Stage IIIB disease (with malignant pleural effusion)
- Stage IV disease
- Recurrent disease
- Measurable or non-measurable disease
- No known CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- No history of hemorrhagic disorders
Hepatic
- Bilirubin < 1.5 mg/dL
- AST and ALT < 5 times upper limit of normal
- INR < 1.5
- PTT normal
Renal
- Creatinine clearance ≥ 45 mL/min
- Urine protein:creatinine ≤ 1.0 by spot urinalysis
Cardiovascular
- No myocardial infarction within the past 6 months
- No New York Heart Association class II-IV congestive heart failure
- No unstable angina pectoris
- No serious cardiac arrhythmia requiring medication
- No stroke within the past 6 months
- No peripheral vascular disease ≥ grade 2
No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
- Patients with a history of hypertension allowed provided blood pressure is well controlled on a stable regimen of anti-hypertensive therapy
- No history of thrombotic disorders
- No other clinically significant cardiovascular disease
Pulmonary
- No history of gross hemoptysis, defined as bright red blood of a ½ teaspoon or more
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be willing and able to take daily oral folic acid, intermittent vitamin B_12 injections, and corticosteroid premedication
- No ongoing or active infection
- No serious, non-healing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 3 weeks since prior immunotherapy
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- More than 3 weeks since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy
Surgery
- More than 4 weeks since prior major surgery
- More than 1 week since prior minor surgery, fine needle aspiration, or core biopsy
- No concurrent major surgery
Other
- Recovered from all prior therapy
- More than 4 weeks since prior and no concurrent participation in another experimental drug study
- No aspirin or other nonsteroidal anti-inflammatory drug (NSAID) 2 days before and 2 days after each pemetrexed disodium infusion (5 days before and 2 days after each pemetrexed disodium infusion for NSAIDs with a long half-life [e.g., naproxen, rofecoxib, or celecoxib])
No concurrent therapeutic anticoagulation
- Concurrent prophylactic anticoagulation for venous access devices allowed provided requirements for INR and PTT are met
No concurrent administration of any of the following:
- Chronic daily treatment with aspirin (> 325 mg per day)
NSAIDs known to inhibit platelet function, including any of the following:
- Dipyridamole
- Ticlopidine
- Clopidogrel
- Cilostazol
Plan de estudios
¿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: Treatment Arm
Carboplatin + pemetrexed + bevacizumab
|
5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)
Otros nombres:
Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)
Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Median Progression Free Survival
Periodo de tiempo: Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)
|
Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause.
Patients that were lost to follow up or withdrew consent were censored at that point.
|
Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall Response Rate
Periodo de tiempo: Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months)
|
Overall Response Rate (ORR) of patients treated with carboplatin, pemetrexed, and bevacizumab combination is defined as the number of patients who's best response is a Complete Response (CR) plus Partial Response (PR)as recorded from the start of treatment until disease progression as assessed by RECIST 1.0. CR=Disappearance of all target lesions for a minimum of 4 weeks. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions for a minimum of 4 weeks, taking as reference the baseline sum LD. No simultaneous increase in the size of any lesion or the appearance of a new lesion may occur. |
Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months)
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Periodo de tiempo: From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51)
|
To characterize the toxicity profile of carboplatin, pemetrexed and bevacizumab combination treatment. Toxicity data will be collected from initiation of treatment, every cycle, until 30 days post last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). Only toxicity determined to be a least possibility related to at least one study drug and grade 3 or 4 was collected for this outcome measure. In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE |
From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51)
|
Overall Survival Rate
Periodo de tiempo: During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.
|
Overall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined from the time of registration to the study until death from any cause.
Patients that are lost to follow up will be censored from last documentation of survival status.
|
During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.
|
Duration of Response
Periodo de tiempo: From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51.
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Duration of Response for patients treated with the combination of carboplatin, pemetrexed and bevacizumab is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date of documented progressive disease.
|
From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Jyoti D. Patel, Robert H. Lurie Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Antagonistas del ácido fólico
- Carboplatino
- Bevacizumab
- Pemetrexed
Otros números de identificación del estudio
- NU 04L2
- NU-04L2
- STU00007415 (Otro identificador: Northwestern University IRB#)
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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