2019
350P Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173)
Wesolowski R, Brufsky A, Chambers M, Bhattacharya S, Lustberg M, VanDeusen J, Sardesai S, Williams N, Noonan A, Phelps M, Grever M, Stephens J, Carson W, Ramaswamy B. 350P Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173). Annals Of Oncology 2019, 30: v126. DOI: 10.1093/annonc/mdz242.045.Peer-Reviewed Original ResearchTriple-negative breast cancerOverall response rateNegative breast cancerBreast cancerDay 1Cancer Therapy Evaluation ProgramCycle 1Clinical benefit rateCommon grade 3Dose level 1Dose-expansion studyHigher adverse eventsPhase Ib studySchedule of paclitaxelAcceptable safety profileProgression-free survivalHeat shock protein 90 inhibitorShock protein 90 inhibitorsNational Cancer InstituteEvaluable ptsPaclitaxel hypersensitivityStudy regimenAdverse eventsMethods PatientsSafety profile
2017
Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple-negative breast cancer (NCT02474173).
Wesolowski R, Lustberg M, Reinbolt R, VanDeusen J, Sardesai S, Williams N, Noonan A, Dewani S, Poi M, Wilson D, Grever M, Stephens J, Puhalla S, Mathew A, Carson W, Ramaswamy B. Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple-negative breast cancer (NCT02474173). Journal Of Clinical Oncology 2017, 35: tps1127-tps1127. DOI: 10.1200/jco.2017.35.15_suppl.tps1127.Peer-Reviewed Original ResearchTriple-negative breast cancerBreast cancerDay 1Hormone receptor-positive breast cancerReceptor-positive breast cancerPhase Ib studyPhase II doseProgression-free survivalPositive breast cancerOverall response rateHeat shock protein 90 inhibitorNegative breast cancerCycle 1Shock protein 90 inhibitorsPoor outcomeStandard doseAndrogen receptorHsp90 client proteinsHeat shock protein 90Ib studyResponse durationToxicity profilePaclitaxel resistanceClient proteinsDay 7
2015
Biomodulation of capecitabine by paclitaxel and carboplatin in advanced solid tumors and adenocarcinoma of unknown primary
Mikhail S, Lustberg M, Ruppert A, Mortazavi A, Monk P, Kleiber B, Villalona-Calero M, Bekaii-Saab T. Biomodulation of capecitabine by paclitaxel and carboplatin in advanced solid tumors and adenocarcinoma of unknown primary. Cancer Chemotherapy And Pharmacology 2015, 76: 1005-1012. PMID: 26416564, DOI: 10.1007/s00280-015-2877-6.Peer-Reviewed Original ResearchMeSH KeywordsActivation, MetabolicAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCarboplatinDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleEnzyme InductionEsophageal NeoplasmsFatigueFemaleGene Expression Regulation, NeoplasticHematologic DiseasesHumansKaplan-Meier EstimateMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNeoplasms, Unknown PrimaryPaclitaxelPancreatic NeoplasmsProdrugsThymidine PhosphorylaseTreatment OutcomeUp-RegulationYoung AdultConceptsAdvanced solid tumorsII studyUnknown primaryDay 1Phase I/II studySolid tumorsPhase IPhase II patientsAntitumor activityObjective response ratePhase II dosePhase II studyMaximal tolerable doseSynergistic antitumor activityCessation of fundingCapecitabine 750Paclitaxel 60Disease stabilizationAcceptable tolerabilityAdvanced adenocarcinomaPartial responseCarboplatin AUCII patientsTolerable dosePatients
2013
Pilot study on the efficacy of an ondansetron- versus palonosetron-containing antiemetic regimen prior to highly emetogenic chemotherapy
Wenzell C, Berger M, Blazer M, Crawford B, Griffith N, Wesolowski R, Lustberg M, Phillips G, Ramaswamy B, Mrozek E, Flynn J, Shapiro C, Layman R. Pilot study on the efficacy of an ondansetron- versus palonosetron-containing antiemetic regimen prior to highly emetogenic chemotherapy. Supportive Care In Cancer 2013, 21: 2845-2851. PMID: 23748485, PMCID: PMC3769492, DOI: 10.1007/s00520-013-1865-9.Peer-Reviewed Original ResearchConceptsDay 1Emetogenic chemotherapyCR rateDay 2Doxorubicin/cyclophosphamide chemotherapyPilot studyOverall complete responseSame patient populationAntiemetic regimenAntiemetic regimensPAD armCyclophosphamide chemotherapyPrimary endpointFeared complicationComplete responseProspective studyPatient populationResultsA totalBreast cancerPatientsRegimensChemotherapyOverall CROndansetronDescriptive statisticsA phase I study of neoadjuvant chemotherapy (NCT) with the gamma secretase (GS) inhibitor RO4929097 in combination with paclitaxel (P) and carboplatin (C) in women with triple-negative breast cancer (TNBC).
Mrozek E, Wesolowski R, Lustberg M, Layman R, Ling Y, Schaaf L, Phelps M, Ivy S, Grever M, Shapiro C. A phase I study of neoadjuvant chemotherapy (NCT) with the gamma secretase (GS) inhibitor RO4929097 in combination with paclitaxel (P) and carboplatin (C) in women with triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2013, 31: 1043-1043. DOI: 10.1200/jco.2013.31.15_suppl.1043.Peer-Reviewed Original ResearchTriple-negative breast cancerMaximum-tolerated doseNon-hematologic toxicitiesNeoadjuvant chemotherapyAUC 5G4 neutropeniaDay 1Gamma secretase inhibitor RO4929097Cycles of NACGrade 4 thrombocytopeniaComplete pathologic responseTreatment-related toxicityMinimal residual cancerMinimal residual diseaseLC-MS/MS assaysAUC 6G3 anemiaG3 fatigueG3 neutropeniaG3 thrombocytopeniaG4 thrombocytopeniaStarting dosePathologic responseResidual cancerOral inhibitor
2010
Phase II Randomized Study of Two Regimens of Sequentially Administered Mitomycin C and Irinotecan in Patients with Unresectable Esophageal and Gastroesophageal Adenocarcinoma
Lustberg M, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, McCracken-Bussa B, Lustberg M, Villalona-Calero M. Phase II Randomized Study of Two Regimens of Sequentially Administered Mitomycin C and Irinotecan in Patients with Unresectable Esophageal and Gastroesophageal Adenocarcinoma. Journal Of Thoracic Oncology 2010, 5: 713-718. PMID: 20354452, PMCID: PMC3641556, DOI: 10.1097/jto.0b013e3181d7776d.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsCamptothecinCarcinoma, Squamous CellEsophageal NeoplasmsEsophagogastric JunctionFemaleHumansIrinotecanLiver NeoplasmsLung NeoplasmsLymphatic MetastasisMaleMiddle AgedMitomycinNeoplasm StagingStomach NeoplasmsSurvival RateTreatment OutcomeConceptsMitomycin CDay 1Day 2Phase II Randomized StudyComplete pathologic responsePhase II evaluationGastroesophageal junction adenocarcinomaUnresectable esophagealEvaluable patientsGastroesophageal adenocarcinomaJunction adenocarcinomaPathologic responseRandomized studyArm AGastroesophageal junctionFuture trialsEsophageal cancerII evaluationSevere toxicityPatientsIrinotecanResponse ratePhase IAdenocarcinomaTopoisomerase 1
2009
Biomodulation of capecitabine by weekly paclitaxel and carboplatin in patients with advanced solid tumor malignancies: A dose-escalating phase I study
Lustberg M, Nuovo J, Thomas J, Monk P, Kim S, Villalona-Calero M, Bekaii-Saab T. Biomodulation of capecitabine by weekly paclitaxel and carboplatin in patients with advanced solid tumor malignancies: A dose-escalating phase I study. Journal Of Clinical Oncology 2009, 27: 2569-2569. DOI: 10.1200/jco.2009.27.15_suppl.2569.Peer-Reviewed Original ResearchDay 1Common grade 3/4 toxicitiesCapecitabine-based treatmentGrade 3/4 toxicitiesAdvanced solid tumorsExpression of TPThymidine phosphorylase activityAUC 6Carboplatin doseWeekly paclitaxelNeutropenic feverPrior therapyTherapeutic indexCapecitabineDose levelsSolid tumorsDay 8Dihydropyrimidine dehydrogenaseCarboplatinMalignant tissuesPhase IPaclitaxelNeutropeniaPatientsPhosphorylase activity