Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC
carboplatin
+ cisplatin
+ irinotecan hydrochloride
Neoplasias bronquiales+7
+ Carcinoma broncogénico
+ Enfermedades del pulmón
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA non-small cell lung cancer. Investigate the phenotypic changes induced in the tumor by this treatment. OUTLINE: Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 3 courses until disease progression. Once potential candidates for resectability are determined, patients undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of completing the last course of chemotherapy. Following resection, patients responding to chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours. Patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel. Chemotherapy ceases if disease remains stable after 8 weeks. Patients are followed every 3 months for the first year after treatment, then every 6 months thereafter for survival. PROJECTED ACCRUAL: This study will accrue 20 patients over 18 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 10 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 confirmed, previously untreated stage IIIa (T1-2 N2 M0) non-small cell lung cancer PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Total bilirubin no greater than 1.5 mg/dL Renal: Creatinine clearance at least 55 mL/min Other: Not HIV positive No active infections Not pregnant or lactating Effective contraception required of fertile patients during study participation No coexisting medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy No concurrent radiation therapy Surgery: Not specified Other: No concurrent use of investigational agents during study participation
Centros 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
Yale Comprehensive Cancer Center
New Haven, United StatesAbrir Yale Comprehensive Cancer Center en Google Maps