A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer
Colección de datos
Enfermedades del Sistema Digestivo+5
+ Neoplasias del sistema digestivo
+ Enfermedades del Sistema Endocrino
Estudio de Tratamiento
Resumen
Phase I Primary Objective: * Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Phase II Primary Objective: * Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Phase II Secondary Objective: * Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 111 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
Inclusion Criteria * Pancreatic cancer (AJCC Stage II-IV); * Unresectable cancer; * Measurable disease (RECIST criteria); * No prior therapy; * ECOG Score 0-2 * Life expectancy greater then or equal to three months; * Adequate hematopoietic, liver and renal function; * Women of child-bearing potential must have negative urine/serum pregnancy test; * Signed written informed consent; * Subjects must be willing to be followed during the course of the treatment/observation and follow-up. Exclusion Criteria: * Prior therapy for pancreatic cancer; * Previously diagnosed brain metastases if symptomatic and requiring active therapy; * Other cancers within the last five years, with the exception of adequately treated cone-biopsied in-situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin; * Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study * Primary or secondary immunodeficiency, or use of corticosteroids immunosuppressive medication; * Women must not be pregnant or breast-feeding; * Participation in any clinical trial involving investigational drugs within one month from enrollment into the present study.