2018
Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open‐Label, Phase I Trial (JVDF)
Arkenau H, Martin‐Liberal J, Calvo E, Penel N, Krebs MG, Herbst RS, Walgren RA, Widau RC, Mi G, Jin J, Ferry D, Chau I. Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open‐Label, Phase I Trial (JVDF). The Oncologist 2018, 23: 1407-e136. PMID: 29853658, PMCID: PMC6292555, DOI: 10.1634/theoncologist.2018-0044.Peer-Reviewed Original ResearchConceptsMetastatic biliary tract cancerTreatment-related adverse eventsBiliary tract cancerObjective response rateProgression-free survivalOverall survivalTract cancerCommon grade 3 treatment-related adverse eventsGrade 3 treatment-related adverse eventsGrade 4 treatment-related adverse eventsDay 1Response rateAdvanced biliary tract cancerMedian progression-free survivalBiomarker-unselected patientsEfficacy of ramucirumabInfrequent grade 3Limited clinical activityPD-1 antagonistsTreatment-related deathsUnexpected safety findingsVEGFR-2 antagonistGrowth factor receptor 2Phase I trialExtrahepatic bile duct
2012
Phase I trial of axitinib combined with platinum doublets in patients with advanced non-small cell lung cancer and other solid tumours
Kozloff MF, Martin LP, Krzakowski M, Samuel TA, Rado TA, Arriola E, De Castro Carpeño J, Herbst RS, Tarazi J, Kim S, Rosbrook B, Tortorici M, Olszanski AJ, Cohen RB. Phase I trial of axitinib combined with platinum doublets in patients with advanced non-small cell lung cancer and other solid tumours. British Journal Of Cancer 2012, 107: 1277-1285. PMID: 22990652, PMCID: PMC3494447, DOI: 10.1038/bjc.2012.406.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPaclitaxel/carboplatinAdvanced non-small cell lung cancerPharmacokinetics of axitinibGemcitabine/cisplatinCell lung cancerAxitinib 5Platinum doubletsLung cancerSolid tumorsSquamous cell non-small cell lung cancerTreatment-related adverse eventsSelective second-generation inhibitorVascular endothelial growth factor receptorObjective response rateDose-limiting toxicityPhase I trialEndothelial growth factor receptorDose-finding trialDrug-drug interactionsPhase I dose-finding trialsCisplatin regimensFebrile neutropeniaGrowth factor receptorExpansion cohortA Multicenter Phase I Trial of PX-866, an Oral Irreversible Phosphatidylinositol 3-Kinase Inhibitor, in Patients with Advanced Solid Tumors
Hong DS, Bowles DW, Falchook GS, Messersmith WA, George GC, O'Bryant CL, Vo AC, Klucher K, Herbst RS, Eckhardt SG, Peterson S, Hausman DF, Kurzrock R, Jimeno A. A Multicenter Phase I Trial of PX-866, an Oral Irreversible Phosphatidylinositol 3-Kinase Inhibitor, in Patients with Advanced Solid Tumors. Clinical Cancer Research 2012, 18: 4173-4182. PMID: 22693357, DOI: 10.1158/1078-0432.ccr-12-0714.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overArea Under CurveDiarrheaDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleEnzyme InhibitorsFatigueFemaleGonanesHumansMaleMetabolic Clearance RateMiddle AgedMutationNauseaNeoplasmsPhosphatidylinositol 3-KinasesPhosphoinositide-3 Kinase InhibitorsTreatment OutcomeVomitingConceptsDose-limiting toxicityArm 1PX-866Stable diseaseArm 2Frequent study drug-related adverse eventsSolid tumorsStudy drug-related adverse eventsDrug-related adverse eventsMulticenter phase I trialGrade III diarrheaAdvanced solid tumorsDose-escalation studyResponse Evaluation CriteriaContinuous dosing scheduleElevated aspartate aminotransferasePhase I trialEvaluable patientsIrreversible small-molecule inhibitorAdverse eventsDosing schedulesI trialAdditional patientsGastrointestinal disordersIncurable cancer
2010
A Multicenter, Phase 2 Study of Vascular Endothelial Growth Factor Trap (Aflibercept) in Platinum- and Erlotinib-Resistant Adenocarcinoma of the Lung
Leighl NB, Raez LE, Besse B, Rosen PJ, Barlesi F, Massarelli E, Gabrail N, Hart LL, Albain KS, Berkowitz L, Melnyk O, Shepherd FA, Sternas L, Ackerman J, Shun Z, Miller VA, Herbst RS. A Multicenter, Phase 2 Study of Vascular Endothelial Growth Factor Trap (Aflibercept) in Platinum- and Erlotinib-Resistant Adenocarcinoma of the Lung. Journal Of Thoracic Oncology 2010, 5: 1054-1059. PMID: 20593550, DOI: 10.1097/jto.0b013e3181e2f7fb.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDrug Resistance, NeoplasmErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedOrganoplatinum CompoundsQuinazolinesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsSalvage TherapySurvival RateTreatment OutcomeConceptsProgression-free survivalLung adenocarcinomaLung cancerResponse rateCommon grade 3/4 toxicitiesMedian progression-free survivalVascular endothelial growth factor trapGrade 5 hemoptysisReversible posterior leukoencephalopathyGrade 3/4 toxicitiesPrimary end pointPhase 2 studyPhase I trialSingle-agent activityDuration of responseOverall response ratePlacental growth factorCardiac ejection fractionProgression of diseaseActivity of VEGFIntravenous afliberceptPosterior leukoencephalopathyIntolerable toxicityOverall survivalCerebral ischemia
2009
Phase I trial of PX-866, a novel phosphoinositide-3-kinase (PI-3K) inhibitor
Jimeno A, Hong D, Hecker S, Clement R, Kurzrock R, Pestano L, Hiscox A, Leos R, Kirkpatrick D, Eckhardt S, Herbst R. Phase I trial of PX-866, a novel phosphoinositide-3-kinase (PI-3K) inhibitor. Journal Of Clinical Oncology 2009, 27: 3542-3542. DOI: 10.1200/jco.2009.27.15_suppl.3542.Peer-Reviewed Original ResearchPX-866Stable diseaseClinical trialsDay 1Drug-related severe adverse eventsMild side effect profilePhase 1 clinical trialStabilization of diseaseSevere adverse eventsDose-limiting toxicityPhase I trialSide effect profileAdvanced metastatic cancerP-mTOR levelsDose-dependent inhibitionLower drug dosesPhosphoinositide-3 kinase inhibitorPD endpointsExpansion cohortLast doseAbdominal discomfortAdverse eventsI trialEffect profileLoss of PTEN
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 IIIClinical, pharmacokinetic (PK), pharmacodynamic findings in a phase I trial of weekly (wkly) intravenous AZD4877 in patients with refractory solid tumors
Infante J, Spratlin J, Kurzrock R, Eckhardt S, Burris H, Puchalski T, Li J, Wu K, Ochs J, Herbst R. Clinical, pharmacokinetic (PK), pharmacodynamic findings in a phase I trial of weekly (wkly) intravenous AZD4877 in patients with refractory solid tumors. Journal Of Clinical Oncology 2008, 26: 2501-2501. DOI: 10.1200/jco.2008.26.15_suppl.2501.Peer-Reviewed Original Research
2007
The changing face of phase I protocols: A closer look at study requirements
Craft B, Kurzrock R, Herbst R, Culotta K, Stewart C, Dorsey V, Lippman S, Gingher D, Bekele N, Karp D. The changing face of phase I protocols: A closer look at study requirements. Journal Of Clinical Oncology 2007, 25: 3061-3061. DOI: 10.1200/jco.2007.25.18_suppl.3061.Peer-Reviewed Original ResearchClinical Translational Research CenterPhase II trialPhase I clinical trialPhase I trialII trialClinical trialsPhase II trialMedical oncologyTranslational Research CenterCancer clinical trialsCurrent phase ILate-phase studiesPhase I programSame time periodTherapeutic requirementsECG monitoringTrialsSignificant financial relationshipElectrocardiographyStudy requirementsOncologyStudy complexityI programMore PKPhase I participants’ views of quality of life and trial participation burdens
Cohen MZ, Slomka J, Pentz RD, Flamm AL, Gold D, Herbst RS, Abbruzzese JL. Phase I participants’ views of quality of life and trial participation burdens. Supportive Care In Cancer 2007, 15: 885-890. PMID: 17252219, DOI: 10.1007/s00520-007-0216-0.Peer-Reviewed Original ResearchConceptsTrial participationCurrent QoLPrevious cancer treatmentPhase I trialPhase I cancer trialsI cancer trialsSymptoms of diseaseStudy drugI trialCancer trialsPhysical complicationsTrial participantsSide effectsQoLCancer treatmentPhase ITrialsPotential participantsBurdenPerception of qualityProcedural burdenRespondent burdenParticipantsTreatmentBaseline ability
2004
Phase I Study of the Farnesyltransferase Inhibitor Lonafarnib with Paclitaxel in Solid Tumors
Khuri FR, Glisson BS, Kim ES, Statkevich P, Thall PF, Meyers ML, Herbst RS, Munden RF, Tendler C, Zhu Y, Bangert S, Thompson E, Lu C, Wang XM, Shin DM, Kies MS, Papadimitrakopoulou V, Fossella FV, Kirschmeier P, Bishop WR, Hong WK. Phase I Study of the Farnesyltransferase Inhibitor Lonafarnib with Paclitaxel in Solid Tumors. Clinical Cancer Research 2004, 10: 2968-2976. PMID: 15131032, DOI: 10.1158/1078-0432.ccr-03-0412.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerGrade 4 diarrheaCell lung cancerPartial responseLung cancerMetastatic non-small cell lung cancerSolid tumorsGrade 3 peripheral neuropathyPrincipal grade 3/4 toxicitiesDose level 3Durable partial responseGrade 3 hyperbilirubinemiaPrevious taxane therapyGrade 3/4 toxicitiesGrade 4 neutropeniaPhase II trialDose-limiting toxicityPhase I trialFarnesyltransferase inhibitor lonafarnibNovel farnesyltransferase inhibitorPlasma paclitaxelII trialTaxane therapyCombination regimenMedian durationGefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1
Giaccone G, Herbst RS, Manegold C, Scagliotti G, Rosell R, Miller V, Natale RB, Schiller JH, von Pawel J, Pluzanska A, Gatzemeier U, Grous J, Ochs JS, Averbuch SD, Wolf MK, Rennie P, Fandi A, Johnson DH. Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1. Journal Of Clinical Oncology 2004, 22: 777-784. PMID: 14990632, DOI: 10.1200/jco.2004.08.001.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCisplatinDeoxycytidineDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGefitinibGemcitabineHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMultivariate AnalysisNeoplasm InvasivenessNeoplasm StagingProbabilityPrognosisQuinazolinesReference ValuesSurvival AnalysisTreatment OutcomeConceptsChemotherapy-naive patientsAdvanced NSCLCLung cancerAdvanced non-small cell lung cancerResponse rateNon-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitor gefitinibEnd pointUnresectable stage IIICycles of chemotherapyEfficacy end pointPhase II trialFirst-line gemcitabineTyrosine kinase inhibitor gefitinibPhase I trialCell lung cancerUnexpected adverse eventsMedian survival timeKinase inhibitor gefitinibFurther preclinical testingDaily gefitinibFavorable tolerabilityII trialPlacebo groupAdverse eventsGefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 2
Herbst RS, Giaccone G, Schiller JH, Natale RB, Miller V, Manegold C, Scagliotti G, Rosell R, Oliff I, Reeves JA, Wolf MK, Krebs AD, Averbuch SD, Ochs JS, Grous J, Fandi A, Johnson DH. Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 2. Journal Of Clinical Oncology 2004, 22: 785-794. PMID: 14990633, DOI: 10.1200/jco.2004.07.215.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug Administration ScheduleFemaleGefitinibHumansInfusions, IntravenousLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMultivariate AnalysisNeoplasm StagingPaclitaxelPredictive Value of TestsPrognosisQuinazolinesReference ValuesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsResponse rateOverall survivalLung cancerActive epidermal growth factor receptor tyrosine kinase inhibitorAdvanced non-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsNon-small cell lung cancerReceptor tyrosine kinase inhibitorsDose-related diarrheaSignificant prolonged survivalUnexpected safety findingsChemotherapy-naive patientsDouble-blind trialPlacebo-controlled trialPhase II trialBaseline demographic characteristicsPhase I trialCell lung cancerConcentration/time curveTyrosine kinase inhibitorsCarboplatin areaDaily gefitinibGefitinib monotherapyMonotherapy trialsQuantitative Analysis of Biomarkers Defines an Optimal Biological Dose for Recombinant Human Endostatin in Primary Human Tumors
Davis DW, Shen Y, Mullani NA, Wen S, Herbst RS, O’Reilly M, Abbruzzese JL, McConkey DJ. Quantitative Analysis of Biomarkers Defines an Optimal Biological Dose for Recombinant Human Endostatin in Primary Human Tumors. Clinical Cancer Research 2004, 10: 33-42. PMID: 14734449, DOI: 10.1158/1078-0432.ccr-0736-3.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsApoptosisBiomarkersCohort StudiesDiagnostic ImagingDose-Response Relationship, DrugEndostatinsEndothelial CellsHumansHypoxia-Inducible Factor 1, alpha SubunitIn Situ Nick-End LabelingNeoplasmsNeovascularization, PathologicPlatelet Endothelial Cell Adhesion Molecule-1Proto-Oncogene Proteins c-bcl-2Recombinant ProteinsTomography, Emission-ComputedTranscription FactorsConceptsHypoxia-inducible factor-1alphaRecombinant human endostatinMicrovessel densityLaser scanning cytometryTC deathHuman endostatinPhase I dose-finding studyTerminal deoxynucleotidyl transferase-mediated nick end labeling stainingTumor cellsEndothelial cellsTumor-associated endothelial cellsSignificant clinical activityFactor-1alphaRefractory solid tumorsCohort of patientsNick end labeling stainingPhase I trialDose-finding studyTumor microvessel densityTumor blood flowOptimal biological doseEnd labeling stainingWhole tissue sectionsPositron emission tomographyPrimary human tumors
2003
Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.
LoRusso PM, Herbst RS, Rischin D, Ranson M, Calvert H, Raymond E, Kieback D, Kaye S, Gianni L, Harris A, Bjork T, Maddox AM, Rothenberg ML, Small EJ, Rubin EH, Feyereislova A, Heyes A, Averbuch SD, Ochs J, Baselga J. Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors. Clinical Cancer Research 2003, 9: 2040-8. PMID: 12796366.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPhase I clinical trialCell lung cancerDisease-related symptomsQuality of lifeAdvanced cancerLung cancerClinical changesClinical trialsOvarian cancerEpidermal growth factor receptor tyrosine kinase inhibitor ZD1839Tumor typesEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsTyrosine kinase inhibitor ZD1839Receptor tyrosine kinase inhibitorsCancer Therapy questionnaireLung Cancer SubscaleMultiple-dose safetyPhase I trialUnited States trialsTyrosine kinase inhibitorsFact QuestionnairePrior therapyTOI scores
2002
Phase I study of recombinant human endostatin in patients with advanced solid tumors.
Herbst RS, Hess KR, Tran HT, Tseng JE, Mullani NA, Charnsangavej C, Madden T, Davis DW, McConkey DJ, O’Reilly M, Ellis LM, Pluda J, Hong WK, Abbruzzese JL. Phase I study of recombinant human endostatin in patients with advanced solid tumors. Journal Of Clinical Oncology 2002, 20: 3792-803. PMID: 12228199, DOI: 10.1200/jco.2002.11.061.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAngiogenesis InhibitorsCollagenCollagen Type XVIIIEndostatinsEndothelial Growth FactorsE-SelectinFemaleFibroblast Growth Factor 2Hematologic DiseasesHumansImmunoglobulinsInfusions, IntravenousLymphokinesMagnetic Resonance ImagingMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPeptide FragmentsRecombinant ProteinsTime FactorsTissue DistributionVascular Cell Adhesion Molecule-1Vascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsRh-EndoConcentration-time curveRecombinant human endostatinSerum markersPreclinical modelsSolid tumorsHuman endostatinDose-limiting toxic effectAntitumor activityTwo-compartmental open modelAdvanced solid tumorsPhase I trialCentral line accessDose-finding trialMinor antitumor activityI trialIntravenous bolusSerum biomarkersSerum antibodiesPharmacokinetic dispositionAllergic reactionsPatientsPharmacokinetic profileDose levelsPhase ISelective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a phase I trial.
Herbst RS, Maddox AM, Rothenberg ML, Small EJ, Rubin EH, Baselga J, Rojo F, Hong WK, Swaisland H, Averbuch SD, Ochs J, LoRusso PM. Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a phase I trial. Journal Of Clinical Oncology 2002, 20: 3815-25. PMID: 12228201, DOI: 10.1200/jco.2002.03.038.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug Administration ScheduleEnzyme InhibitorsFemaleGastrointestinal DiseasesGefitinibHead and Neck NeoplasmsHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingNeoplasmsProtein-Tyrosine KinasesQuinazolinesSkin DiseasesConceptsDose-limiting toxicityPharmacokinetic analysisEpidermal growth factor receptor tyrosine kinase inhibitor ZD1839Epidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsGrade 1/2 adverse eventsTyrosine kinase inhibitor ZD1839Primary dose-limiting toxicityReceptor tyrosine kinase inhibitorsPrior cancer therapyAntitumor activityDaily oral dosingPhase I trialCell lung cancerTyrosine kinase inhibitorsSolid tumor typesVariability of exposureStable diseaseAdverse eventsPartial responseUndue toxicityI trialTolerability trialCell lungFollicular rashStudy of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial.
Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Daniel Ayers G, Herbst RS, Abbruzzese JL. Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial. Journal Of Clinical Oncology 2002, 20: 3785-91. PMID: 12228198, DOI: 10.1200/jco.2002.04.084.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAttitude to HealthClinical Trials, Phase I as TopicCollagenData CollectionDecision MakingEndostatinsFemaleHumansInformed ConsentMaleMass MediaMiddle AgedMotivationNeoplasmsPatient ParticipationPeptide FragmentsPhysiciansProspective StudiesResearch DesignSurveys and QuestionnairesConceptsPercent of respondentsPhase I clinical trialPhase I trialHuman recombinant endostatinI trialClinical trialsTrial investigatorsResearch participants' understandingTrialsEndostatinPhysiciansRecombinant endostatinPotential influencePercentProspective participantsTrial purposesSurvey respondentsPersonal benefitsParticipants' understandingPatientsRespondents
2001
Gemcitabine and vinorelbine in patients with advanced lung cancer: preclinical studies and report of a phase I trial
Herbst R, Lynch C, Vasconcelles M, Teicher B, Strauss G, Elias A, Anderson I, Zacarola P, Dang N, Leong T, Salgia R, Skarin A. Gemcitabine and vinorelbine in patients with advanced lung cancer: preclinical studies and report of a phase I trial. Cancer Chemotherapy And Pharmacology 2001, 48: 151-159. PMID: 11561781, DOI: 10.1007/s002800100282.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerAdvanced lung cancerDana-Farber Cancer InstituteLung cancerDose levelsMouse Lewis lung cancer modelLewis lung cancer modelMedian ECOG performance statusMouse Lewis lung carcinoma modelPhase I clinical studyDay 15 doseDose level 4ECOG performance statusLewis lung carcinoma modelCentral venous lineEfficacy of gemcitabinePhase I trialCell lung cancerLung cancer modelAbility of patientsHighest dose levelLung carcinoma modelHematologic toxicityChemotherapeutic regimenI trialClinical studies of angiogenesis inhibitors: The university of texas md anderson center trial of human endostatin
Herbst R, Lee A, Tran H, Abbruzzese J. Clinical studies of angiogenesis inhibitors: The university of texas md anderson center trial of human endostatin. Current Oncology Reports 2001, 3: 131-140. PMID: 11177745, DOI: 10.1007/s11912-001-0013-8.Peer-Reviewed Original ResearchConceptsPhase I trialI trialClinical studiesHuman endostatinTumor vasculatureSolid tumor malignanciesAnti-angiogenic agentsAnti-angiogenic mechanismAnti-angiogenic compoundsToxic cancer treatmentsAdvanced diseaseBlood vessel supplyCenter trialMinimal diseaseTumor sizeNovel agentsSurrogate endpointsNew agentsSide effectsBiologic mechanismsSingle agentAngiogenesis inhibitorsGrowth-inhibiting moleculesNon-toxic agentsTumor growth
2000
Objective regressions in non-small cell lung cancer patients treated in Phase I trials of oral ZD1839 (IressaTM), a selective tyrosine kinase inhibitor that blocks the epidermal growth factor receptor (EGFR)
Kris M, Herbst R, Rischin D, LoRusso P, Baselga J, Hammond L, Feyereislova A, Ochs J, Averbuch S. Objective regressions in non-small cell lung cancer patients treated in Phase I trials of oral ZD1839 (IressaTM), a selective tyrosine kinase inhibitor that blocks the epidermal growth factor receptor (EGFR). Lung Cancer 2000, 29: 72. DOI: 10.1016/s0169-5002(00)80233-0.Peer-Reviewed Original ResearchEpidermal growth factor receptorNon-small cell lung cancer patientsCell lung cancer patientsPhase I trialSelective tyrosine kinase inhibitorLung cancer patientsTyrosine kinase inhibitorsGrowth factor receptorObjective regressionI trialCancer patientsOral ZD1839Kinase inhibitorsFactor receptorPatientsZD1839