2023
A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial
Malarkey M, Toscano A, Bagheri M, Solomon J, Machado L, LoRusso P, Chen A, Folio L, Goncalves P. A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial. Heliyon 2023, 9: e18680. PMID: 37593628, PMCID: PMC10428039, DOI: 10.1016/j.heliyon.2023.e18680.Peer-Reviewed Original ResearchACC patientsClinical trialsTarget lesionsSolid tumorsPhase II clinical trialPilot studyPhase 2 trialResponse Evaluation CriteriaSalivary gland cancerRare salivary gland cancerSystemic therapy efficacyStable diseaseGland cancerLung lesionsComputed tomography (CT) examsCystic carcinomaTherapy responseBlinded observersTomography examsTherapy efficacyLesionsInter-observer variationPatientsAppropriate evaluationTrials
2022
Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials
LoRusso P, Freidlin B. Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials. Journal Of The National Cancer Institute 2022, 115: 122-124. PMID: 36448688, PMCID: PMC9905964, DOI: 10.1093/jnci/djac212.Peer-Reviewed Original ResearchPraluzatamab Ravtansine, a CD166-Targeting Antibody–Drug Conjugate, in Patients with Advanced Solid Tumors: An Open-Label Phase I/II Trial
Boni V, Fidler MJ, Arkenau HT, Spira A, Meric-Bernstam F, Uboha N, Sanborn RE, Sweis RF, LoRusso P, Nagasaka M, Garcia-Corbacho J, Jalal S, Harding JJ, Kim SK, Miedema IHC, Vugts DJ, Huisman MC, Zwezerijnen GJC, van Dongen GAMS, van Oordt C, Wang S, Dang T, Zein IA, Vasiljeva O, Lyman SK, Paton V, Hannah A, Liu JF. Praluzatamab Ravtansine, a CD166-Targeting Antibody–Drug Conjugate, in Patients with Advanced Solid Tumors: An Open-Label Phase I/II Trial. Clinical Cancer Research 2022, 28: 2020-2029. PMID: 35165101, PMCID: PMC9365353, DOI: 10.1158/1078-0432.ccr-21-3656.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsOpen-label phase I/II trialSolid tumorsPhase I/II trialPhase I/II clinical trialsBasis of tolerabilityPhase II doseBreast cancer subsetsAntibody-drug conjugatesProtease-cleavable linkerEligible patientsPosttreatment biopsiesPrior therapyStable diseaseII trialPartial responseSafety profileTumor regressionClinical trialsPrevalent subtypeCancer subsetsClinical activityMetastatic cancerBreast cancerMedian number
2021
The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective
Sessa C, Cortes J, Conte P, Cardoso F, Choueiri T, Dummer R, Lorusso P, Ottmann O, Ryll B, Mok T, Tempero M, Comis S, Oliva C, Peters S, Tabernero J. The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective. ESMO Open 2021, 7: 100339. PMID: 34953404, PMCID: PMC8608656, DOI: 10.1016/j.esmoop.2021.100339.Peer-Reviewed Original ResearchConceptsInnovative clinical trialsClinical trialsOncology clinical trialsOncology clinical researchClinical researchCancer careClinical trial stakeholdersTrial stakeholdersNew treatmentsPatient accessCancer clinical trialsCOVID-19COVID-19 pandemicNew trial designsFaster patient accessWorldwide clinical trialsClinical trial objectivesOncology expertsOutcome dataTrial designTrial objectivesTrialsRecent dataCareInternational panel
2020
Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center
Hong D, Marcelo-Lewis K, LoRusso P. Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center. 2020, 71-83. DOI: 10.1007/978-3-030-47682-3_4.Peer-Reviewed Original Research
2017
P2.03a-065 Lack of Drug-Drug Interaction (DDI) between Necitumumab and Gemcitabine or Cisplatin: A Phase 2, Open-Label, Nonrandomized Study Topic: Clinical Trials
Chaudhary A, Chao G, Braiteh F, Gordon M, Lee J, Lorusso P, Obasaju C, Wallin J. P2.03a-065 Lack of Drug-Drug Interaction (DDI) between Necitumumab and Gemcitabine or Cisplatin: A Phase 2, Open-Label, Nonrandomized Study Topic: Clinical Trials. Journal Of Thoracic Oncology 2017, 12: s928-s929. DOI: 10.1016/j.jtho.2016.11.1275.Peer-Reviewed Original Research
2016
Antibody–Drug Conjugates (ADCs) in Clinical Development
McLaughlin J, LoRusso P. Antibody–Drug Conjugates (ADCs) in Clinical Development. 2016, 321-344. DOI: 10.1002/9781119060727.ch13.Peer-Reviewed Original ResearchAntibody-drug conjugatesCytotoxic agentsMonoclonal antibodiesLocal immune responseFavorable safety profileConventional cytotoxic chemotherapyConventional cytotoxic agentsDifferent antibody–drug conjugatesImmune-stimulating agentsAnti-neoplastic agentsCytotoxic chemotherapySafety profileCancer patientsIL-2Clinical trialsImmune responseClinical developmentOncologist's abilityImproved efficacyPhase IDrug conjugatesAntibodiesEfficacyTarget effectsToxicityTrabectedin (T)-related liver toxicity: Results of a pharmacokinetic study with T in patients with hepatic dysfunction (OVC1004) and experience from a phase 3 clinical trial (SAR3007).
Calvo E, Azaro A, Dirix L, Huizing M, Senecal F, LoRusso P, Yee L, Keung C, Triantos S, Park Y, Knoblauch R, Parekh T, Demetri G, vonMehren M. Trabectedin (T)-related liver toxicity: Results of a pharmacokinetic study with T in patients with hepatic dysfunction (OVC1004) and experience from a phase 3 clinical trial (SAR3007). Journal Of Clinical Oncology 2016, 34: 11064-11064. DOI: 10.1200/jco.2016.34.15_suppl.11064.Peer-Reviewed Original Research
2014
882PD Phase 1/2 Study of Oral Rucaparib: Updated Phase 1 and Preliminary Phase 2 Results
Kristeleit R, Shapira-Frommer R, Burris H, Patel M, Lorusso P, Oza A, Balmaña J, Domchek S, Chen L, Montes A, Plummer R, Arkenau H, Maloney L, Dominy E, Shapiro G. 882PD Phase 1/2 Study of Oral Rucaparib: Updated Phase 1 and Preliminary Phase 2 Results. Annals Of Oncology 2014, 25: iv307. DOI: 10.1093/annonc/mdu338.8.Peer-Reviewed Original ResearchAdvanced solid tumorsDurable benefitSolid tumorsDana-Farber Cancer InstituteHighest LOHCA-125 responsePhase 1/2 studyDose-escalation designPhase 1Homologous recombination-deficient tumorsOral PARP inhibitorClinical trial fundingPhase 2CA125 responseCommon AEsOral rucaparibRelapsed diseaseLow HgbEscalation designLow plateletsClinical benefitLab abnormalitiesBRCA mutationsPancreatic cancerClinical trials
2012
Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab.
Modi S, Elias A, LoRusso P, Samant M, Guardino E, Althaus B, Krop I. Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. Journal Of Clinical Oncology 2012, 30: 528-528. DOI: 10.1200/jco.2012.30.15_suppl.528.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerMetastatic breast cancerT-DM1Prior systemic therapyPhase Ib studyPhase II studyDose-escalation studySingle-agent activityDuration of responseDose escalation schemeFuture clinical trialsDLT criteriaII studyMedian ageSystemic therapyExtension trialPreclinical dataTrastuzumab emtansineClinical trialsMedian numberToxicity CriteriaBreast cancerIb studyPhase IbQ3w
2009
Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan
Vishnu P, Jasti P, Ding L, Heilbrun L, Venkatramanamoorthy R, LoRusso P, Heath E. Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan. Journal Of Clinical Oncology 2009, 27: e20626-e20626. DOI: 10.1200/jco.2009.27.15_suppl.e20626.Peer-Reviewed Original ResearchKarmanos Cancer InstitutePhase 1 clinical trialOverall survivalClinical trialsPhase ICommon grade 3Median overall survivalPerformance status 1Retrospective chart reviewClinical trial participationYears of ageChart reviewElderly patientsElectrolyte abnormalitiesPatient agePatient demographicsPS 0Biologic agentsMedian ageStatus 1Lack of enrollmentRetrospective studyCombination therapyPatient subgroupsStudy criteria
2007
Barriers to phase I clinical trial protocol IRB approval at KCI
Wang D, Heath E, Powell A, Chaperon T, LaGrone F, LoRusso P. Barriers to phase I clinical trial protocol IRB approval at KCI. Journal Of Clinical Oncology 2007, 25: 9080-9080. DOI: 10.1200/jco.2007.25.18_suppl.9080.Peer-Reviewed Original ResearchInstitutional review boardClinical trialsIRB approvalMedian timePhase 1 clinical trialPhase 1 trialPhase 1 protocolPatient accrualAnti-cancer drug developmentStudy designProtocol approvalReview boardFinal approvalPhase IDrug development processSignificant financial relationshipTrialsApproval statusAverage timeHuman subjectsDrug developmentMolecular therapeuticsApprovalInitial review
2002
Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition.
Albanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro J, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. Journal Of Clinical Oncology 2002, 20: 110-24. PMID: 11773160, DOI: 10.1200/jco.2002.20.1.110.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic AgentsApoptosisBiomarkersCell Cycle ProteinsCyclin-Dependent Kinase Inhibitor p27Dose-Response Relationship, DrugErbB ReceptorsFemaleGefitinibHumansKeratinocytesMaleMAP Kinase Signaling SystemMiddle AgedNeoplasmsQuinazolinesSkinStatistics, NonparametricTumor Suppressor ProteinsConceptsCancer patientsEpidermal growth factor receptor tyrosine kinase inhibitor ZD1839Tyrosine kinase inhibitor ZD1839Phase I clinical trialMaximum-tolerated doseDose-limiting toxicityEGFR activationReceptor-dependent processUnacceptable toxicityDefinitive efficacyPharmacodynamic assessmentSafety trialPharmacodynamic effectsClinical trialsKeratin plugsReceptor inhibitionMaturation markersSkin biopsiesPharmacodynamic studiesProliferation indexDose levelsOral ZD1839PatientsOptimal dosesZD1839
2001
Analysis of skeletal-related events in breast cancer and response to therapy
LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. PMID: 11544572, DOI: 10.1016/s0093-7754(01)90228-3.Peer-Reviewed Original ResearchConceptsBone metastasesSkeletal morbiditySkeletal complicationsSkeletal related eventsTreatment of choiceBone painIntravenous pamidronateBisphosphonate treatmentSignificant morbidityCancer patientsPotent bisphosphonateStandard treatmentBone resorptionSurrogate markerClinical trialsCommon siteMetastatic cancerBreast cancerMorbidityMetastasisPatientsLife measurementsTherapyComplicationsPamidronate
1999
Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit
Simon M, Brown D, Du W, LoRusso P, Kellogg C. Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit. American Journal Of Clinical Oncology 1999, 22: 42-46. PMID: 10025379, DOI: 10.1097/00000421-199902000-00011.Peer-Reviewed Original ResearchConceptsBreast cancer clinical trialsClinical trialsCancer clinical trialsBreast cancerLarge urban university hospitalFemale breast cancer patientsEarly-stage diseaseUrban university hospitalBreast cancer patientsAvailable studiesUniversity Affiliated HospitalStage diseasePatient barriersMedical oncologistsBreast servicesPatient enrollmentCancer patientsPatient raceUniversity HospitalPractice patternsMost womenTrialsWomenEnrollment processMetropolitan Detroit
1995
Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934).
LoRusso P, Foster B, Poplin E, McCormick J, Kraut M, Flaherty L, Heilbrun L, Valdivieso M, Baker L. Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934). Clinical Cancer Research 1995, 1: 1487-93. PMID: 9815948.Peer-Reviewed Original ResearchConceptsGrade IV toxicityStarting doseDose escalationClinical trialsPhase I clinical trialNext dose escalationAcceptable toxicity profilePhase II trialDose-limiting toxicityPeak plasma levelsPre-clinical efficacyMultidrug-resistant tumor cellsMurine solid tumorsII trialTreatment coursePlasma levelsGrade IInterpatient variationIntermediate dosePreclinical characteristicsToxicity profilePharmacokinetic parametersDose levelsSolid tumorsTotal doseTumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents
Corbett T, Valeriote F, Lorusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lowichik N, Biernat L, Foster B, Wozniak A, Lisow L, Valdivieso M, Baker L, Leopold W, Sebolt J, Bissery M, Mattes K, Dzubow J, Rake J, Perni R, Wentland M, Coughlin S, Shaw J, Liversidge G, Liversidge E, Bruno J, Sarpotdar P, Moore R, Patterson G. Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents. Pharmaceutical Biology 1995, 33: 102-122. DOI: 10.3109/13880209509067092.Peer-Reviewed Original ResearchSCID miceNude miceTumor modelHuman tumorsHuman tumor xenograft modelsUnique histologic appearanceXenograft model systemAthymic nude miceHuman tumor modelsUnique biologic entityTumor xenograft modelClass of agentsNormal cellsDrug response profilesActivity testingTumor takeSolid tumor cellsVariety of agentsClinical trialsBiologic behaviorHistologic appearanceNew agentsXenograft modelSingle tumorSolid tumors
1994
Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues
Corbett T, Lowichik N, Pugh S, Polin L, Panchapor C, White K, Knight J, Demchik L, Jones J, Jones L, Biernat L, Lorusso P, Foster B, Heilbrun L, Rake J, Mattes K, Perni R, Powles R, Hlavac A, Wentland M, Coughlin S, Baker L, Valeriote F. Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues. Expert Opinion On Investigational Drugs 1994, 3: 1281-1292. DOI: 10.1517/13543784.3.12.1281.Peer-Reviewed Original ResearchLiver toxicityAntitumour activityClinical trialsPhase I clinical trialSevere liver toxicityEfficacious dose levelsPreclinical modelsDose levelsBetter efficacyWeekly scheduleAntischistosomal agentsDay scheduleHycanthoneM2 levelToxicityTrialsMost analoguesAgentsRecovery timeVariety of analoguesGroupActivityMiceDoseRandomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer
Poplin E, LoRusso P, Lokich J, Gullo J, Leming P, Schulz J, Veach S, McCulloch W, Baker L, Schein P. Randomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer. Cancer Chemotherapy And Pharmacology 1994, 33: 415-419. PMID: 8306416, DOI: 10.1007/bf00686271.Peer-Reviewed Original ResearchConceptsColorectal cancerMyelosuppressive potentialRefractory colorectal cancerMetastatic colorectal cancerAdvanced colorectal cancerRandomized clinical trialsUse of mitomycinRefractory colorectal carcinomaMitomycin therapyPlatelet nadirsHematologic toxicityPrincipal toxicityPartial responseClinical trialsColorectal carcinomaSame dosePatientsMitomycinCancerThrombocytopeniaTherapyToxicityGroupPretreatmentFluorouracil