Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer
Colección de datos
Enfermedades del colon+13
+ Enfermedades del Sistema Digestivo
+ Neoplasias del sistema digestivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2004
Fecha en la que se inscribió al primer participante.Patients that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Sources may be used in a single lesion or in multiple lesions. Following radiographic confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 40 mg/m². Fifteen minutes to 1 hour following completion of LS11 administration, delivery of 200 J/cm at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for acute complication of Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and be maintained as defined throughout the study period. On day 3 following Litx™ treatment the patient will receive a standard chemotherapy with Irinotecan or Oxaliplatin with or without 5FU and /or leucovorin for metastatic colorectal cancer. On day 30+5 and day 60+5 the patient will undergo clinical assessment and the tumor mass will be imaged using contrast enhanced spiral CT for determination of volume and radius of PDT necrosis.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 25 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: * Patients with metastatic liver lesions from colorectal disease * Biopsy proven evidence of colorectal cancer * Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter * Age greater than or equal to 18 years * Patients must be able to sign informed consent * Life expectancy greater than or equal to 3 months * ECOG performance status 0-2 * Patients with extrahepatic disease in addition to their hepatic metastases may be eligible * Must have recovered from the toxicity from any prior antineoplastic therapy Exclusion Criteria: * Patients who are candidates for complete surgical resection * Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment * Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study * PT or PTT greater than 1.5X control * Platelet count less than 100,000 * WBC less than 2500/mm * Neutrophils less than 2000/mm * Hemoglobin less than 9 g/dL * Liver enzymes (AST, ALT, GGT, alkaline phosphatase) greater than 3 X ULN * Total bilirubin greater than 1.5 X ULN * Serum creatinine greater than 2.5 X ULN * Patients who have been treated with either AVASTIN™ (Bevacizumab) or ERBITUX™ (Cetuximab) within the previous 4 weeks (28 days)
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