Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
Colección de datos
Enfermedades de la Mama+2
+ Neoplasias de la Mama
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 2002
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Determine the maximum tolerated dose of capecitabine and irinotecan in women with advanced breast cancer. * Determine the degree of accumulation of cells in S-phase in tumor biopsies from patients treated with this regimen. * Determine the dose-limiting toxicity and other major or unusual toxic effects of this regimen in these patients. * Determine any antitumor activity of this regimen in these patients. * Determine the pharmacokinetics of this regimen, including the active metabolite SN-38, in these patients. * Correlate pharmacokinetic parameters of this regimen with the biological changes observed in these patients. * Determine, preliminarily, the relationship of tumor response with modulation of S-phase in patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive irinotecan IV over 1.5 hours on days 1, 8, 22, and 29 and oral capecitabine twice daily on days 1-14 and 23-36. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine 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. PROJECTED ACCRUAL: A total of 8-37 patients will be accrued for this study within 18-24 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 12 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.Mujer
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: * Diagnosis of breast cancer not eligible for potentially curative therapy or studies of higher priority * Advanced disease * Tumor accessible to biopsy AND not irradiated * Failed at least 1 prior chemotherapy regimen (not including adjuvant chemotherapy) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * AST ≤ 2 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active uncontrolled bacterial, viral, or fungal infection * No poor medical risk from non-malignant systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * Prior irinotecan allowed * Prior carboplatin allowed * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy except for small port radiotherapy for local control Surgery * More than 4 weeks since prior major surgery Other * No concurrent high-dose IV cyclosporine
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