2022
Phase II Study of Enzalutamide for Patients With Androgen Receptor–Positive Salivary Gland Cancers (Alliance A091404)
Ho AL, Foster NR, Zoroufy AJ, Campbell JD, Worden F, Price K, Adkins D, Bowles DW, Kang H, Burtness B, Sherman E, Morton R, Morris LGT, Nadeem Z, Katabi N, Munster P, Schwartz GK. Phase II Study of Enzalutamide for Patients With Androgen Receptor–Positive Salivary Gland Cancers (Alliance A091404). Journal Of Clinical Oncology 2022, 40: 4240-4249. PMID: 35867947, PMCID: PMC9916043, DOI: 10.1200/jco.22.00229.Peer-Reviewed Original ResearchConceptsSalivary gland cancerPrimary end pointProgression-free survivalAndrogen receptorStable diseaseEnd pointOverall survivalPartial responseGland cancerTumor regressionPartial response/stable diseaseBest overall response rateMedian progression-free survivalResponse/stable diseaseHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Common adverse eventsMedian overall survivalPhase II studySecondary end pointsPhase II trialFree testosterone levelsGrowth factor receptor 2Overall response rateProgression of disease
2021
Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).
Bauman J, Saba N, Roe D, Bauman J, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Saboda K, Obara S, Chung C. Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2021, 39: 6015-6015. DOI: 10.1200/jco.2021.39.15_suppl.6015.Peer-Reviewed Original ResearchMedian progression-free survivalOverall response rateHepatocyte growth factorAdvanced HNSCCPartial responsePrimary endpointEvaluable subjectsHPV statusRecurrent/metastatic HNSCCAnti-EGFR monoclonal antibodiesNeck squamous cell carcinomaMajor prognostic variablesPerformance status 0Phase II trialProgression-free survivalNon-comparative trialsSquamous cell carcinomaConfidence intervalsPhase III investigationFC combinationDual pathway inhibitionLFT elevationsPFS endpointPrior cetuximabStatus 0
2011
Significance of Pathologic Response to Preoperative Therapy in Pancreatic Cancer
Chun YS, Cooper HS, Cohen SJ, Konski A, Burtness B, Denlinger CS, Astsaturov I, Hall MJ, Hoffman JP. Significance of Pathologic Response to Preoperative Therapy in Pancreatic Cancer. Annals Of Surgical Oncology 2011, 18: 3601-3607. PMID: 21947697, DOI: 10.1245/s10434-011-2086-4.Peer-Reviewed Original ResearchConceptsPathologic response ratePathologic responsePreoperative therapyPancreatic adenocarcinomaResponse rateComplete pathologic response rateMajor pathologic response rateMajor pathologic responseNegative lymph nodesImportant prognostic factorMinority of patientsSmaller tumor sizeMedian survival rateR0 resectionConsecutive patientsPancreatic headPartial responsePrognostic factorsImproved survivalLymph nodesTumor sizeHistopathologic examinationMinor responsePancreatic cancerTherapy occurs
2009
Phase II trial of docetaxel–irinotecan combination in advanced esophageal cancer
Burtness B, Gibson M, Egleston B, Mehra R, Thomas L, Sipples R, Quintanilla M, Lacy J, Watkins S, Murren JR, Forastiere AA. Phase II trial of docetaxel–irinotecan combination in advanced esophageal cancer. Annals Of Oncology 2009, 20: 1242-1248. PMID: 19429872, PMCID: PMC2699385, DOI: 10.1093/annonc/mdn787.Peer-Reviewed Original ResearchConceptsAdvanced esophageal cancerPartial responseComplete responseEligible patientsEsophageal cancerEastern Cooperative Oncology Group performance statusMetastatic squamous cell carcinomaSafety of docetaxelPhase II trialSquamous cell carcinomaPrincipal toxic effectsAssessable patientsEsophagogastric cancerMeasurable diseaseToxic deathsII trialCN patientsMedian survivalPerformance statusNormal bilirubinPreclinical evidenceMedian timeCell carcinomaMyocardial infarctionTumor assessment
2008
A randomized phase II study of ixabepilone (BMS-247550) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study
Burtness BA, Manola J, Axelrod R, Argiris A, Forastiere AA. A randomized phase II study of ixabepilone (BMS-247550) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study. Annals Of Oncology 2008, 19: 977-983. PMID: 18296423, DOI: 10.1093/annonc/mdm591.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCombined Modality TherapyDisease-Free SurvivalDocetaxelDrug Administration ScheduleDrug Resistance, NeoplasmEpothilonesFemaleHead and Neck NeoplasmsHematologic DiseasesHumansInfusions, IntravenousMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesRecurrenceSalvage TherapySurvival AnalysisTaxoidsConceptsTaxane-naive patientsArm BEastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group StudyRecurrent squamous cell cancerSensory/motor neuropathyRandomized phase II studyMetastatic/recurrent diseaseCommon grade 3Grade 3 neuropathyPhase II studyPrimary end pointSquamous cell cancerSquamous cell carcinomaEligible patientsPrior regimensWeekly ixabepiloneRecurrent diseaseII studyMedian survivalPartial responsePerformance statusMotor neuropathyCell cancerCell carcinoma
2007
Phase II Trial of Weekly Docetaxel/Irinotecan Combination in Advanced Pancreatic Cancer
Burtness B, Thomas L, Sipples R, McGurk M, Salikooti S, Christoforou M, Mirto G, Salem R, Sosa J, Kloss R, Rahman Z, Chung G, Lacy J, Murren JR. Phase II Trial of Weekly Docetaxel/Irinotecan Combination in Advanced Pancreatic Cancer. The Cancer Journal 2007, 13: 257-262. PMID: 17762761, DOI: 10.1097/ppo.0b013e31813c1174.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic cancerPancreatic cancerEligible patientsIrinotecan combinationPartial responseComplete responseEastern Cooperative Oncology Group performance status 0Principal grade 3/4 toxicitiesWorld Health Organization criteriaSafety of docetaxelGrade 3/4 toxicitiesObjective response ratePerformance status 0One-year survivalPhase II trialCombination of docetaxelNormal bilirubin levelsEvaluable patientsFebrile neutropeniaMeasurable diseaseStatus 0Toxic deathsUnresectable diseaseII trialRecurrent disease
2006
A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck
Burtness B, Goldwasser M, Axelrod R, Argiris A, Forastiere A. A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck. Journal Of Clinical Oncology 2006, 24: 5532-5532. DOI: 10.1200/jco.2006.24.18_suppl.5532.Peer-Reviewed Original ResearchArm BEligible ptsArm A.Recurrent squamous cell cancerRandomized phase II studyMetastatic/recurrent diseaseECOG PS 0Grade 3/4 anemiaPhase II studySquamous cell cancerDiphenhydramine premedicationMales 69Prior regimensRecurrent SCCHNTaxane exposurePrimary endpointII studyMedian survivalPartial responseProgressive diseasePS 0Recurrent diseaseMotor neuropathyArm ACell cancer
2002
Phase I Dose Escalation Trial of Weekly Docetaxel Plus Irinotecan in Patients with Advanced Cancer
Bleickardt E, Argiris A, Rich R, Blum K, McKeon A, Tara H, Zelterman D, Burtness B, Davies MJ, Murren JR. Phase I Dose Escalation Trial of Weekly Docetaxel Plus Irinotecan in Patients with Advanced Cancer. Cancer Biology & Therapy 2002, 1: 646-651. PMID: 12642688, DOI: 10.4161/cbt.314.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityWeek of restWeekly docetaxelPancreatic cancerDose levelsSolid tumorsPredominant dose-limiting toxicityCommon dose-limiting toxicityNon-small cell lungPhase II dosesNausea/vomitingAdvanced solid tumorsMaximum-tolerated dosePhase II trialPhase I trialNonhematologic toxicityEligible patientsEscalation trialII trialPartial responseSevere neutropeniaWeekly administrationI trialAdvanced cancerCell lung
2000
Dose escalation and pharmacokinetic study of irinotecan in combination with paclitaxel in patients with advanced cancer
Murren J, Peccerillo K, DiStasio S, Li X, Leffert J, Pizzorno G, Burtness B, McKeon A, Cheng Y. Dose escalation and pharmacokinetic study of irinotecan in combination with paclitaxel in patients with advanced cancer. Cancer Chemotherapy And Pharmacology 2000, 46: 43-50. PMID: 10912577, DOI: 10.1007/s002800000115.Peer-Reviewed Original ResearchConceptsDose of irinotecanElimination of irinotecanDrug AdministrationAdvanced cancerFirst cycle patientsChemotherapy-related toxicityDose of paclitaxelClinical side effectsSequence of administrationBlood cell elementsNonhematologic toxicityReversible neutropeniaFirst doseMost patientsPartial responseCycle patientsDose escalationMild diarrheaPreclinical dataPlasma concentrationsSide effectsIrinotecanPatientsPharmacokinetic parametersWeekly schedulePhase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin.
Baselga J, Pfister D, Cooper MR, Cohen R, Burtness B, Bos M, D’Andrea G, Seidman A, Norton L, Gunnett K, Falcey J, Anderson V, Waksal H, Mendelsohn J. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. Journal Of Clinical Oncology 2000, 18: 904-14. PMID: 10673534, DOI: 10.1200/jco.2000.18.4.904.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsArea Under CurveCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCetuximabCisplatinDose-Response Relationship, DrugDrug Administration ScheduleErbB ReceptorsFemaleGene Expression Regulation, NeoplasticHead and Neck NeoplasmsHumansInfusions, IntravenousLung NeoplasmsMaleNeoplasms, Glandular and EpithelialRecombinant Fusion ProteinsRemission InductionSafetyConceptsAntibody dosesMultiple doseSystemic clearancePhase I clinical trialWeeks of therapyDose-dependent pharmacokineticsCell lung cancerChimeric monoclonal antibodyCoadministration of cisplatinEpidermal growth factor receptorMurine chimeric monoclonal antibodyGrowth factor receptorDisease stabilizationPartial responseAdvanced tumorsSingle doseLung cancerClinical trialsDisease progressionEpithelial tumorsNonlinear pharmacokineticsPatientsDose levelsAntibody C225Relevant doses