2010
Phase I Dose-Escalation Study of Recombinant Human Apo2L/TRAIL, a Dual Proapoptotic Receptor Agonist, in Patients With Advanced Cancer
Herbst RS, Eckhardt SG, Kurzrock R, Ebbinghaus S, O'Dwyer PJ, Gordon MS, Novotny W, Goldwasser MA, Tohnya TM, Lum BL, Ashkenazi A, Jubb AM, Mendelson DS. Phase I Dose-Escalation Study of Recombinant Human Apo2L/TRAIL, a Dual Proapoptotic Receptor Agonist, in Patients With Advanced Cancer. Journal Of Clinical Oncology 2010, 28: 2839-2846. PMID: 20458040, DOI: 10.1200/jco.2009.25.1991.Peer-Reviewed Original ResearchConceptsRecombinant human Apo2L/TRAILRhApo2L/TRAILDose-escalation studyAdverse eventsAdvanced cancerLiver metastasesDose escalationLiver functionApo2L/TRAILI dose-escalation studyDurable partial responseRapid tumor necrosisAntitumor activityCommon adverse eventsLiver enzyme elevationMetastatic liver diseaseSerious adverse eventsAbnormal liver functionNormal liver functionMultiple intravenous dosesNecrosis factor-related apoptosis-inducing ligandPreclinical antitumor efficacyTumor necrosis factor-related apoptosis-inducing ligandFactor-related apoptosis-inducing ligandHuman clinical trials
2008
Dose Escalation of Gemcitabine Is Possible With Concurrent Chest Three-Dimensional Rather Than Two-Dimensional Radiotherapy: A Phase I Trial in Patients With Stage III Non–Small-Cell Lung Cancer
Zinner RG, Komaki R, Cox JD, Glisson BS, Pisters KM, Herbst RS, Kies M, Liao Z, Hong WK, Fossella FV. Dose Escalation of Gemcitabine Is Possible With Concurrent Chest Three-Dimensional Rather Than Two-Dimensional Radiotherapy: A Phase I Trial in Patients With Stage III Non–Small-Cell Lung Cancer. International Journal Of Radiation Oncology • Biology • Physics 2008, 73: 119-127. PMID: 18556142, DOI: 10.1016/j.ijrobp.2008.03.069.Peer-Reviewed Original ResearchMeSH KeywordsAbdomenAdultAgedAged, 80 and overAntimetabolites, AntineoplasticCarcinoma, Non-Small-Cell LungCombined Modality TherapyDeoxycytidineDose-Response Relationship, DrugDose-Response Relationship, RadiationFeasibility StudiesFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedRadiation-Sensitizing AgentsRadiotherapy, ConformalTreatment OutcomeConceptsGrade 3 esophagitisDose of gemcitabineCell lung cancerTwo-dimensional radiotherapyLung cancerThree-dimensional conformal radiotherapySevere acute esophagitisWeekly gemcitabine concurrentCycles of gemcitabinePhase II doseStage III NSCLCDose-limiting toxicityPhase I trialThree-dimensional CRTChest radiotherapyConcurrent chestConcurrent radiotherapySevere esophagitisAcute esophagitisI trialDose escalationConformal radiotherapyEsophagitisApparent diseaseStage III
2006
Phase I Dose Escalation and Pharmacokinetic Study of Enzastaurin, an Oral Protein Kinase C Beta Inhibitor, in Patients With Advanced Cancer
Carducci MA, Musib L, Kies MS, Pili R, Truong M, Brahmer JR, Cole P, Sullivan R, Riddle J, Schmidt J, Enas N, Sinha V, Thornton DE, Herbst RS. Phase I Dose Escalation and Pharmacokinetic Study of Enzastaurin, an Oral Protein Kinase C Beta Inhibitor, in Patients With Advanced Cancer. Journal Of Clinical Oncology 2006, 24: 4092-4099. PMID: 16943527, DOI: 10.1200/jco.2005.05.3447.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic AgentsDose-Response Relationship, DrugDrug Administration ScheduleFemaleFlow CytometryGene Expression Regulation, EnzymologicGene Expression Regulation, NeoplasticHumansIndolesMaleMiddle AgedNeoplasmsProtein Kinase CProtein Kinase C betaProtein Kinase InhibitorsConceptsMaximum-tolerated doseProtein kinase C beta inhibitorStable diseaseAdvanced cancerEastern Cooperative Oncology Group performance statusSignificant grade 3/4 toxicityBeta inhibitorGrade 3/4 toxicitiesPhase II dosePhase II trialDose-limiting toxicityYears of ageExpansion cohortGI toxicityII trialStarting dosePerformance statusDose escalationAdditional patientsNeck cancerPrevalent malignancySafety dataPatientsSecondary objectiveEnzastaurin