2000
Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin.
Baselga J, Pfister D, Cooper MR, Cohen R, Burtness B, Bos M, D’Andrea G, Seidman A, Norton L, Gunnett K, Falcey J, Anderson V, Waksal H, Mendelsohn J. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. Journal Of Clinical Oncology 2000, 18: 904-14. PMID: 10673534, DOI: 10.1200/jco.2000.18.4.904.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsArea Under CurveCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCetuximabCisplatinDose-Response Relationship, DrugDrug Administration ScheduleErbB ReceptorsFemaleGene Expression Regulation, NeoplasticHead and Neck NeoplasmsHumansInfusions, IntravenousLung NeoplasmsMaleNeoplasms, Glandular and EpithelialRecombinant Fusion ProteinsRemission InductionSafetyConceptsAntibody dosesMultiple doseSystemic clearancePhase I clinical trialWeeks of therapyDose-dependent pharmacokineticsCell lung cancerChimeric monoclonal antibodyCoadministration of cisplatinEpidermal growth factor receptorMurine chimeric monoclonal antibodyGrowth factor receptorDisease stabilizationPartial responseAdvanced tumorsSingle doseLung cancerClinical trialsDisease progressionEpithelial tumorsNonlinear pharmacokineticsPatientsDose levelsAntibody C225Relevant doses
1998
Phase I clinical and pharmacological studies of benzylacyclouridine, a uridine phosphorylase inhibitor.
Pizzorno G, Yee L, Burtness BA, Marsh JC, Darnowski JW, Chu MY, Chu SH, Chu E, Leffert JJ, Handschumacher RE, Calabresi P. Phase I clinical and pharmacological studies of benzylacyclouridine, a uridine phosphorylase inhibitor. Clinical Cancer Research 1998, 4: 1165-75. PMID: 9607574.Peer-Reviewed Original ResearchConceptsPreclinical studiesDose levelsUridine concentrationPhase I clinical trialGrade 1 constipationGrade 1 elevationGrade 1 fatigueGrade 1 feverGrade 2 anemiaOral dose levelsSingle oral doseTreatment of patientsPlasma uridine concentrationBiochemical end pointsFirst-order clearanceAverage peak concentrationCancer cell linesAdvanced cancerOral dosePlasma levelsPlasma uridineClinical trialsPlasma concentrationsSustained elevationTracer dose