Evaluation of Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash
Collecte de données
Néoplasmes bronchiques+10
+ Carcinome du poumon non à petites cellules
+ Carcinome bronchogénique
Soins de support
Résumé
Date de début de l'étude : 1 octobre 2008
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires