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
A first-in-human phase I trial of AR-12, a PDK-1 inhibitor, in patients with advanced solid tumors.
Mateo J, De Bono J, Ramanathan R, Lustberg M, Zivi A, Basset D, Ng M, Young A, Garrett M, Decordova S, Raynaud F, Yap T, Zukiwski A, Proniuk S, Shapiro C. A first-in-human phase I trial of AR-12, a PDK-1 inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2608-2608. DOI: 10.1200/jco.2013.31.15_suppl.2608.Peer-Reviewed Original ResearchPlatelet-rich plasmaAdvanced solid tumorsAR-12PK variabilitySafety dataFood effectSolid tumorsHuman phase I trialAdequate organ functionECOG PS 0Phase II doseDose-escalation studyPhase I trialDrug-related eventsHuman clinical trialsHigh PK variabilityCOX-2 inhibitory activityMechanism of actionBID cohortQD cohortStable diseaseStudy drugPS 0I trialSingle dose
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