2015
A Phase I Study of CUDC-101, a Multitarget Inhibitor of HDACs, EGFR, and HER2, in Combination with Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma
Galloway TJ, Wirth LJ, Colevas AD, Gilbert J, Bauman JE, Saba NF, Raben D, Mehra R, W. A, Atoyan R, Wang J, Burtness B, Jimeno A. A Phase I Study of CUDC-101, a Multitarget Inhibitor of HDACs, EGFR, and HER2, in Combination with Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma. Clinical Cancer Research 2015, 21: 1566-1573. PMID: 25573383, PMCID: PMC6607903, DOI: 10.1158/1078-0432.ccr-14-2820.Peer-Reviewed Original ResearchConceptsHuman growth factor receptor 2Peripheral blood mononuclear cellsEpidermal growth factor receptorDose-limiting toxicityAdverse eventsCUDC-101Tumor biopsiesHistone deacetylaseNeck squamous cell cancerNeck squamous cell carcinomaHigh-risk HNSCCGrowth factor receptor 2Squamous cell cancerSquamous cell carcinomaBlood mononuclear cellsExternal beam radiationTreatment of HNSCCRoute of administrationOne-week runFactor receptor 2Concurrent cisplatinGrowth factor receptorRisk patientsCell cancerCell carcinoma
2010
Initial Results of a Phase I Dose-Escalation Trial of Concurrent and Maintenance Erlotinib and Reirradiation for Recurrent and New Primary Head-and-Neck Cancer
Rusthoven KE, Feigenberg SJ, Raben D, Kane M, Song JI, Nicolaou N, Mehra R, Burtness B, Ridge J, Swing R, Lango M, Cohen R, Jimeno A, Chen C. Initial Results of a Phase I Dose-Escalation Trial of Concurrent and Maintenance Erlotinib and Reirradiation for Recurrent and New Primary Head-and-Neck Cancer. International Journal Of Radiation Oncology • Biology • Physics 2010, 78: 1020-1025. PMID: 20231078, DOI: 10.1016/j.ijrobp.2009.09.003.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCarcinoma, Squamous CellCetuximabCombined Modality TherapyDrug Administration ScheduleErlotinib HydrochlorideFeasibility StudiesFemaleFollow-Up StudiesGastrostomyHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsQuinazolinesRadiotherapy DosageRetreatmentTreatment OutcomeConceptsDose-limiting toxicityMaintenance erlotinibPrimary HNCCohort IIICohort IINeck cancerCohort IPrimary headRadiation therapyPhase I dose-escalation trialPercutaneous endoscopic gastrostomy (PEG) tube placementAcute grade 3 toxicityGrade 4 acute toxicityI dose-escalation trialEndoscopic gastrostomy tube placementGrade 3 dysphagiaGrade 3 osteoradionecrosisNew primary headGrade 3 toxicityDose-escalation trialPhase I trialGastrostomy tube placementErlotinib dailyMaintenance therapyPrior radiation
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
A phase I study of the antimetabolite (E)-2'-fluoromethylene-2'-deoxycytidine (MDL 101,731) administered as a twice-weekly infusion.
Burtness B, Belker M, Stoltz M, Peccerillo KM, Lamb LA, Chmael SE, McKeon A, Clark MB, Winship J, Marsh JC, Pizzorno G, DeVita VT. A phase I study of the antimetabolite (E)-2'-fluoromethylene-2'-deoxycytidine (MDL 101,731) administered as a twice-weekly infusion. The Cancer Journal 2000, 6: 309-15. PMID: 11079170.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityRest weekNovel antimetaboliteWeekly scheduleHuman tumor xenograft modelsWeeks of therapyLife-threatening toxicityPhase I trialFrequent dosing scheduleTumor xenograft modelIndicator lesionsNoninfectious feverPersistent neutropeniaStable diseaseWeekly infusionsDose escalationDosing schedulesI trialRectal cancerAdvanced cancerInitial doseMonths durationXenograft modelPatientsPreclinical tests