Evaluation of Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash
Colección de datos
Carcinoma de pulmón no microcítico+9
+ Carcinoma broncogénico
+ Neoplasias bronquiales
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de octubre de 2008
Fecha en la que se inscribió al primer participante.A side effect occurring in a majority of patients taking erlotinib (Tarceva®) consists of a skin rash. Sometimes, symptoms associated with the rash necessitate erlotinib dose reduction or discontinuation. Some physicians have successfully treated the erlotinib-induced rash with doxycycline. At the same time, it has been observed that in patients who develop the erlotinib rash, the cancers respond better to erlotinib treatment. This research study is designed to determine how well doxycycline treats the erlotinib rash and whether doxycycline affects the blood levels of erlotinib.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Cuidados de Apoyo
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: * Males and females 18 years of age or older. * Subjects must have started Tarceva® therapy within three (3) days of trial enrollment. * Patients must have signed informed consent prior to registration on study. * Currently receiving erlotinib therapy at 150 mg per day for locally advanced or metastatic NSCLC. * Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must utilize barrier methods in combination with spermicidal agents for contraception when engaging in sexual intercourse. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration. Exclusion Criteria: * Allergy to tetracyclines. * Use of concurrent agents for papulopustular rash. * Currently receiving anticancer agents other than erlotinib. * Inability to interrupt other antibiotic therapy. * Current use of topical steroids * Current use of systemic immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine, mycophenolate mofetil) * Photosensitivity or lupus erythematosus. * Active gastroesophageal reflux disease. * Women who have a positive pregnancy test or are lactating by history. * ECOG performance status ≤3. * Self report of current smoking or history of smoking within 60 days of screening, or positive urine cotinine test. * Current use of agents that are known to be strong inducers or inhibitors of CYTP3A4: * inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfi navir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, grapefruit or grapefruit juice * inducers: rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, and St. John's Wort * Impaired hepatic function (≤ 30 days before randomization): * Alkaline phosphatase \> 3x ULN * Aspartate aminotransferase (AST) \> x ULN * Alanine aminotransferase (ALT) \> 3 x ULN * Total Bilirubin \> 1.5 x ULN
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios