- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00316225
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Hannover, Alemania, 30625
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kobenhavn, Dinamarca, 2100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, España, 28041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) or mesothelioma
- Presence of third-space fluid (fluid around the lungs or abdomen).
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the sharp toxic effects the anticancer treatment.
- Estimated life expectancy of at least 8 weeks.
Exclusion Criteria:
- Have received treatment within the last 30 days with a drug that was not a marketed product.
- Active infection that, in the opinion of the investigator, would not allow the patient to tolerate therapy.
- Pregnancy.
- Breast-feeding.
- Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry.
- Brain metastases.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Pemetrexed
Pemetrexed 500 mg/m^2 intravenous (IV) every 21 days for 6 cycles
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500 milligrams per meter squared (mg/m^2) IV every 21 days for 6 cycles
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overview of Adverse Events
Periodo de tiempo: baseline, up to 18 weeks
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Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship.
Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline.
An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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baseline, up to 18 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Periodo de tiempo: baseline, up to 18 weeks
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Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening. NOS = Not otherwise specified. |
baseline, up to 18 weeks
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Pemetrexed Population Pharmacokinetics (PK): Clearance
Periodo de tiempo: Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion
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Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time.
Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.
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Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion
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Pemetrexed Population Pharmacokinetics: Volume of Distribution
Periodo de tiempo: Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion
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Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma.
Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration.
By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated.
Central volume (V1) was determined by dose/peak serum level of pemetrexed.
Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.
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Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion
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Discontinuations Due to Adverse Events
Periodo de tiempo: baseline, up to 18 weeks
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Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.
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baseline, up to 18 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall Tumor Response
Periodo de tiempo: baseline, up to 18 weeks
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Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions. PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions. SD (stable disease) = small changes that do not meet above criteria. |
baseline, up to 18 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Adenoma
- Neoplasias Mesoteliales
- Neoplasias Pleurales
- Neoplasias Pulmonares
- Mesotelioma
- Mesotelioma Maligno
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes antineoplásicos
- Antagonistas del ácido fólico
- Pemetrexed
Otros números de identificación del estudio
- 10426
- H3E-MC-JMHX (Otro identificador: Eli Lilly and Company)
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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