A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer
Erlotinib
+ Bevacizumab
+ Paclitaxel
Enfermedades del Sistema Digestivo+6
+ Neoplasias del sistema digestivo
+ Enfermedades del esófago
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 2007
Fecha en la que se inscribió al primer participante.Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery. Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks). Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 62 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: * Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III * No prior treatment for esophageal cancer * Must be surgical candidate based on stage and location of disease * Measurable or evaluable disease * Able to be up and perform self care * Adequate liver, renal function and bone marrow function * Patients will have to have a central venous access device placed * Able to give written informed consent. * Age 18 or older Exclusion Criteria: * Stage IV disease * Prior cancer treatment for advanced cancer in the last 5 years * Pregnant or lactating women * History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease * History of neurological disease * Recent history of blood in the sputum or vomitus * Non-healing wounds, ulcer or long bone fractures * History of bleeding problems or coagulation problems * History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months * History of uncontrolled hypertension Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
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
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 9 ubicaciones
Integrated Community Oncology Network
Jacksonville, United StatesNortheast Georgia Medical Center
Gainesville, United StatesConsultants in Blood Disorders and Cancer
Louisville, United States