- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00020124
Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have advanced solid tumors affecting the lungs.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients.
- Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks and 3 months.
PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 18-24 months.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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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 proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery
- Clinical evidence of primary lung or tracheal cancer OR
- Metastatic cancer to the lung
Extrathoracic metastases eligible if following criteria are met:
- Sites are stable
- Pulmonary sites are primary life-threatening sites
- Evidence that study treatment may benefit the patient
- Measurable or evaluable disease
- No germ cell tumor, leukemia, or lymphoma involving the lungs that is treatable with systemic agents
- No complete atelectasis due to high-grade airway obstruction
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.0 mg/dL
- AST and ALT less than 1.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- LVEF at least 40% by MUGA scan or echocardiogram
- No unstable angina, congestive heart failure, or symptomatic arrhythmias
Pulmonary:
- DLCO at least 50% predicted
- FVC and FEV1 at least 50% predicted
- Resting oxygen saturation at least 90%
- Exercise oxygen saturation at least 85%
- Oxygen consumption greater than 50% predicted
- No prior radiation pneumonitis
- No asthma
- No radiation-induced pulmonary damage
Other:
- No hypersensitivity to doxorubicin
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- HIV negative
- No congenital problems (e.g., cleft palate) or other anomalies that prevent tight fit of a mouthseal
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy and recovered
- No prior trastuzumab (Herceptin)
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- Prior doxorubicin allowed if LVEF at least 40% by MUGA scan or echocardiogram
- No prior mitomycin, bleomycin, or nitrosoureas
- No other concurrent systemic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- At least 12 months since prior radiotherapy to chest
- No prior radiotherapy to more than 20% of total lung volume
- Prior chest wall or primary breast radiotherapy allowed
- Prior radioactive iodine allowed
- No concurrent thoracic radiotherapy
Surgery:
- See Disease Characteristics
- No prior total pneumonectomy
Other:
- No other concurrent experimental drug
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
- cáncer de pulmón de células no pequeñas recurrente
- cáncer de pulmón de células pequeñas en estadio extenso
- cáncer de pulmón de células pequeñas recurrente
- cáncer de pulmón de células no pequeñas en estadio IIIB
- cáncer de pulmón de células no pequeñas en estadio IV
- mesotelioma maligno avanzado
- mesotelioma maligno recurrente
- metástasis pulmonares
- tumor carcinoide pulmonar
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 enzimas
- Agentes antineoplásicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Doxorrubicina
- Doxorrubicina liposomal
Otros números de identificación del estudio
- 000088 (FSRG #1 IRB)
- 00-C-0088
- CDR0000067718
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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