A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH CHEST IRRADIATION
topotecan hydrochloride
+ radiation therapy
Neoplasias bronquiales+7
+ Carcinoma broncogénico
+ Enfermedades del pulmón
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 1993
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the maximum tolerated dose of topotecan and chest irradiation in patients with non-small cell lung cancer. II. Determine the qualitative and quantitative toxic effects of this regimen in these patients. III. Determine the degree of antitumor activity of this regimen in these patients. OUTLINE: This is a dose escalation study of topotecan and thoracic radiotherapy. Beginning on day 1, patients receive topotecan IV continuously for 3-6 weeks and thoracic radiotherapy 5 days a week for 2, 3, or 6 weeks. Cohorts of 4-6 patients receive escalating doses of topotecan and thoracic radiotherapy until the maximum tolerated dose (MTD) of each therapy is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Six additional patients are treated at the MTD. Patients who fail to achieve complete remission (CR) and continue to have measurable disease at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21 at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123. Treatment continues every 4 weeks in the absence of unacceptable toxicity.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer Eligible for chest irradiation with 3,000 to 6,000 cGy (based upon standard radiotherapy indications) Measurable or evaluable disease Measurable disease defined as bidimensionally measurable lesion on physical exam or radiograph (CT or MRI acceptable) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: At least 12 weeks WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal Creatinine no greater than 1.5 mg/dL Not pregnant or nursing PRIOR CONCURRENT THERAPY: No more than 1 prior chemotherapy regimen allowed At least 4 weeks since prior chemotherapy and recovered No prior radiotherapy Recovered from toxic effects of any prior therapy
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalCentros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, United StatesAbrir NYU School of Medicine's Kaplan Comprehensive Cancer Center en Google Maps