2009
Phase II randomized study of biomarker-directed treatment for non-small cell lung cancer (NSCLC): The BATTLE (Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination) clinical trial program
Kim E, Herbst R, Lee J, Blumenschein G, Tsao A, Wistuba I, Alden C, Gupta S, Stewart D, Hong W. Phase II randomized study of biomarker-directed treatment for non-small cell lung cancer (NSCLC): The BATTLE (Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination) clinical trial program. Journal Of Clinical Oncology 2009, 27: 8024-8024. DOI: 10.1200/jco.2009.27.15_suppl.8024.Peer-Reviewed Original ResearchNon-small cell lung cancerLung cancerRecurrent non-small cell lung cancerTreatment-related adverse eventsECOG PS 0Progression-free statusAdvanced lung cancerClinical trial programCell lung cancerCore needle biopsyBRAF gene mutationCyclin D1 amplificationBiomarker analysisEligible ptsEvaluable ptsPrior chemotherapyPrimary endpointAdverse eventsPS 0Pneumothorax rateTumor responseNeedle biopsyEGFR polysomyBRAF mutationsFresh biopsies
2007
A clinical trial design applying Bayesian adaptive randomization for targeted therapy development in lung cancer: A step toward personalized medicine
Zhou X, Kim E, Herbst R, Liu S, Wistuba I, Mao L, Lewis J, Lippman S, Hong W, Lee J. A clinical trial design applying Bayesian adaptive randomization for targeted therapy development in lung cancer: A step toward personalized medicine. Journal Of Clinical Oncology 2007, 25: 7697-7697. DOI: 10.1200/jco.2007.25.18_suppl.7697.Peer-Reviewed Original ResearchBiomarker profilesEffective agentResponse rateRandomization ratesLung Cancer EliminationTumor biomarker profilesClinical trial designBayesian adaptive randomizationCancer ptsPrior chemotherapyTreatment armsClinical efficacyLung cancerCancer eliminationEffective therapyLung carcinogenesisTargeted therapyDifferent biomarker profilesTrial designTreatment efficacyBiopsy samplesTherapy trialsPatient entryBiomarker expressionTherapy
2006
Safety and pharmacokinetics (PK) of AMG 706, panitumumab, and carboplatin/paclitaxel (CP) for the treatment of patients (pts) with advanced non-small cell lung cancer (NSCLC)
Blumenschein G, Sandler A, O’Rourke T, Eschenberg M, Sun Y, Gladish G, Salgia R, Alden C, Herbst R, Reckamp K. Safety and pharmacokinetics (PK) of AMG 706, panitumumab, and carboplatin/paclitaxel (CP) for the treatment of patients (pts) with advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2006, 24: 7119-7119. DOI: 10.1200/jco.2006.24.18_suppl.7119.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerCarboplatin/paclitaxelAMG 706Epidermal growth factor receptorDose cohortsStage IIIB/IV non-small cell lung cancerTreatment-related adverse eventsPhase 1b studyAntitumor activityObjective response rateCell lung cancerTreatment of patientsDirect antitumor activityMulti-kinase inhibitorHuman monoclonal antibodyPreliminary dataCNS metastasisGrowth factor receptorPrior chemotherapyQD cohortAdverse eventsMedian ageECOG scoreAcceptable safety
2005
Phase II study of pemetrexed in combination with carboplatin in the first‐line treatment of advanced nonsmall cell lung cancer
Zinner RG, Fossella FV, Gladish GW, Glisson BS, Blumenschein GR, Papadimitrakopoulou VA, Pisters KM, Kim ES, Oh YW, Peeples BO, Ye Z, Curiel RE, Obasaju CK, Hong WK, Herbst RS. Phase II study of pemetrexed in combination with carboplatin in the first‐line treatment of advanced nonsmall cell lung cancer. Cancer 2005, 104: 2449-2456. PMID: 16258975, DOI: 10.1002/cncr.21480.Peer-Reviewed Original ResearchConceptsAdvanced nonsmall cell lung cancerNonsmall cell lung cancerCell lung cancerPerformance statusLung cancerSerum concentration-time curveGrade 3/4 thrombocytopeniaNonhematologic side effectsZubrod performance statusGrade 3/4 neutropeniaPartial response ratePercent of patientsPhase II studyStage IV diseaseFirst-line therapyFirst-line treatmentConcentration-time curveCarboplatin areaPrior chemotherapyStage IIIBII studyMedian ageMedian timeSensory neuropathyMedian numberO-187 Efficacy and safety of single agent pertuzumab (rhuMAb 2C4), a HER dimerization inhibitor, in Non-Small Cell Lung Cancer (NSCLC) patients after prior chemotherapy
Herbst R, Davies A, Johnson B, Natale R, Dang T, Murren J, Schiller J, Garland L, Miller V, Mendelson D, Melenevsky Y, Devries D, Van Den Abbeele A, Eberhard D, Lyons B, Lutzker S. O-187 Efficacy and safety of single agent pertuzumab (rhuMAb 2C4), a HER dimerization inhibitor, in Non-Small Cell Lung Cancer (NSCLC) patients after prior chemotherapy. Lung Cancer 2005, 49: s62. DOI: 10.1016/s0169-5002(05)80321-6.Peer-Reviewed Original ResearchPhase I/II Trial Evaluating the Anti-Vascular Endothelial Growth Factor Monoclonal Antibody Bevacizumab in Combination With the HER-1/Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Erlotinib for Patients With Recurrent Non–Small-Cell Lung Cancer
Herbst RS, Johnson DH, Mininberg E, Carbone DP, Henderson T, Kim ES, Blumenschein G, Lee JJ, Liu DD, Truong MT, Hong WK, Tran H, Tsao A, Xie D, Ramies DA, Mass R, Seshagiri S, Eberhard DA, Kelley SK, Sandler A. Phase I/II Trial Evaluating the Anti-Vascular Endothelial Growth Factor Monoclonal Antibody Bevacizumab in Combination With the HER-1/Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Erlotinib for Patients With Recurrent Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2005, 23: 2544-2555. PMID: 15753462, DOI: 10.1200/jco.2005.02.477.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug InteractionsErlotinib HydrochlorideFemaleHumansInfusions, IntravenousLung NeoplasmsMaleMiddle AgedProtein Kinase InhibitorsQuinazolinesSurvival AnalysisTreatment OutcomeConceptsPhase II doseCell lung cancerLung cancerHumanized anti-vascular endothelial growth factor monoclonal antibodyVascular endothelial growth factor monoclonal antibody bevacizumabAnti-vascular endothelial growth factor monoclonal antibodyPhase I/II studyPhase I/II trialStage IIIB/IV NSCLCEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsEpidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinibTyrosine kinase inhibitor erlotinibReceptor tyrosine kinase inhibitorsCommon adverse eventsMedian overall survivalProgression-free survivalDose-limiting toxicityFactor monoclonal antibodyMonoclonal antibody bevacizumabKinase inhibitor erlotinibTyrosine kinase inhibitorsAdenocarcinoma histologyModerate rashPrior chemotherapy
2002
Safety and pharmacokinetic effects of TNP-470, an angiogenesis inhibitor, combined with paclitaxel in patients with solid tumors: evidence for activity in non-small-cell lung cancer.
Herbst RS, Madden TL, Tran HT, Blumenschein GR, Meyers CA, Seabrooke LF, Khuri FR, Puduvalli VK, Allgood V, Fritsche HA, Hinton L, Newman RA, Crane EA, Fossella FV, Dordal M, Goodin T, Hong WK. Safety and pharmacokinetic effects of TNP-470, an angiogenesis inhibitor, combined with paclitaxel in patients with solid tumors: evidence for activity in non-small-cell lung cancer. Journal Of Clinical Oncology 2002, 20: 4440-7. PMID: 12431966, DOI: 10.1200/jco.2002.04.006.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntibiotics, AntineoplasticAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCyclohexanesDrug Administration ScheduleFemaleHumansLung NeoplasmsMaleMiddle AgedO-(Chloroacetylcarbamoyl)fumagillolPaclitaxelSesquiterpenesTreatment OutcomeConceptsTNP-470Solid tumorsPharmacokinetic interactionsOptimal doseAntiangiogenic agent TNP-470Minimal pharmacokinetic interactionsNeuropsychiatric test resultsSingle-agent doseMaximum-tolerated doseDoses of paclitaxelCell lung cancerPaclitaxel dosePrior chemotherapyChemotherapy regimensCombination regimenMedian survivalPartial responseArm AArm BPaclitaxel clearanceTreatment armsCytotoxic therapyLung cancerPharmacokinetic effectsPreclinical studies