2023
Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer
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, Klein R, Saboda K, Obara S, Chung C. Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer. Journal Of Clinical Oncology 2023, 41: 3851-3862. PMID: 36977289, DOI: 10.1200/jco.22.01994.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalProgression-free survivalObjective response rateRecurrent/metastatic headCMET overexpressionMetastatic headCombination armAntiepidermal growth factor receptor monoclonal antibodyNoncomparative phase II studyRecurrent/metastatic HNSCCRandomized phase II trialEnd pointNeck squamous cell carcinomaHPV negative subgroupPhase II studyPrimary end pointSecondary end pointsHPV-positive diseaseHuman papillomavirus (HPV) statusMajor prognostic factorPhase II trialKey eligibility criteriaSquamous cell carcinomaReceptor monoclonal antibodyHPV-negative HNSCC
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
2020
71P A phase II study of ADU-S100 in combination with pembrolizumab in adult patients with PD-L1+ recurrent or metastatic HNSCC: Preliminary safety, efficacy and PK/PD results
Zandberg D, Ferris R, Laux D, Mehra R, Nabell L, Kaczmar J, Gibson M, Kim Y, Neupane P, Bauman J, Julian R, Adkins D, Cohen E, Burtness B, Bermingham C, Dupage A, Desbien A, Loi A, Nuyten D, Saba N. 71P A phase II study of ADU-S100 in combination with pembrolizumab in adult patients with PD-L1+ recurrent or metastatic HNSCC: Preliminary safety, efficacy and PK/PD results. Annals Of Oncology 2020, 31: s1446-s1447. DOI: 10.1016/j.annonc.2020.10.559.Peer-Reviewed Original ResearchRandomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Bauman J, Roe D, Saba N, Bauman J, Kaczmar J, Burtness B, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Bhatia A, Giri A, Caulin C, Stabile L, Centuori S, Chung C. Randomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6594-tps6594. DOI: 10.1200/jco.2020.38.15_suppl.tps6594.Peer-Reviewed Original ResearchProgression-free survivalOverall response rateM HNSCCPhase II trialHepatocyte growth factorII trialCetuximab resistanceMulticenter phase II trialRecurrent/metastatic headTotal peripheral T cellsRandomized phase II trialExpression of HGFPoor progression-free survivalNeck squamous cell carcinomaPeripheral immune profileKey secondary endpointPhase II studyKey eligibility criteriaSquamous cell carcinomaPeripheral T cellsPI3K/AktIgG1 monoclonal antibodyTwo-arm designECOG 0EGFR monotherapy
2019
Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201.
Iqbal S, McDonough S, Lenz HJ, Ilson D, Burtness B, Nangia CS, Barzi A, Schneider CJ, Liu JJ, Dotan E, Guthrie KA, Hochster HS. Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201. Journal Of Clinical Oncology 2019, 38: 472-479. PMID: 31815582, PMCID: PMC7007287, DOI: 10.1200/jco.19.00925.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDNA-Binding ProteinsEndonucleasesEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilGene ExpressionHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsOxaliplatinPrognosisProgression-Free SurvivalProportional Hazards ModelsProspective StudiesStomach NeoplasmsYoung AdultConceptsProgression-free survivalAdvanced esophagogastric cancerPhase II studyPlatinum-based therapyOverall survivalII studySuperior median progression-free survivalMedian progression-free survivalMRNA expressionRegimen of irinotecanUpper GI tumorsZubrod performance statusPercent of patientsOccurrence of gradeStandard of careMetastatic esophagealEsophagogastric cancerPerformance statusUntreated patientsGastroesophageal cancerGI tumorsTreatment armsFOLFOXPlatinum sensitivityPatientsAlliance A091404: A phase II study of enzalutamide (NSC# 766085) for patients with androgen receptor-positive salivary cancers.
Ho A, Foster N, Zoroufy A, Worden F, Price K, Adkins D, Bowles D, Kang H, Burtness B, Sherman E, Morton R, Katabi N, Munster P, Schwartz G. Alliance A091404: A phase II study of enzalutamide (NSC# 766085) for patients with androgen receptor-positive salivary cancers. Journal Of Clinical Oncology 2019, 37: 6020-6020. DOI: 10.1200/jco.2019.37.15_suppl.6020.Peer-Reviewed Original ResearchProgression-free survivalSalivary gland cancerProgression of diseaseAndrogen receptorOverall survivalStable diseaseMedian progression-free survivalGood responsePhase II studyFirst prospective trialPhase II trialEligible patientsPrior therapyRECIST v1.1Salivary cancerUnconfirmed PRHormonal therapyII trialPrimary endpointSecondary endpointsII studyProspective trialGland cancerClinical activityConfirmatory scan
2017
A randomized phase II pilot study prospectively evaluating treatment for patients based on ERCC1 for advanced/ metastatic esophageal, gastric, or gastroesophageal junction cancer: SWOG S1201.
Iqbal S, McDonough S, Lenz H, Ilson D, Burtness B, Nangia C, Barzi A, Schneider C, Liu J, Dotan E, Guthrie K, Hochster H. A randomized phase II pilot study prospectively evaluating treatment for patients based on ERCC1 for advanced/ metastatic esophageal, gastric, or gastroesophageal junction cancer: SWOG S1201. Journal Of Clinical Oncology 2017, 35: 4009-4009. DOI: 10.1200/jco.2017.35.15_suppl.4009.Peer-Reviewed Original ResearchAdvanced esophagogastric cancerERCC1 levelsRandomized phase II pilot studyRandomized phase II studyPhase II pilot studyHigh ERCC1 levelsPhase II studyHER2-negative patientsGastroesophageal junction cancerDifferential treatment effectsMetastatic esophagealEsophagogastric cancerII studyJunction cancerNegative patientsPS 0Superior PFSERCC1 expressionTx groupFOLFOXPlatinum sensitivityRetrospective dataPFSHigh subgroupPilot study
2016
CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers
Enzinger PC, Burtness BA, Niedzwiecki D, Ye X, Douglas K, Ilson DH, Villaflor VM, Cohen SJ, Mayer RJ, Venook A, Benson AB, Goldberg RM. CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers. Journal Of Clinical Oncology 2016, 34: 2736-2742. PMID: 27382098, PMCID: PMC5019745, DOI: 10.1200/jco.2015.65.5092.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionDisease-Free SurvivalEpirubicinEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsSurvival RateTime FactorsTreatment FailureConceptsGastroesophageal junction cancerProgression-free survivalMetastatic esophagealJunction cancerOverall survivalTreatment failureResponse rateMedian progression-free survivalRandomized phase II studyContinuous infusion fluorouracilOptimal chemotherapy backboneTreatment-related deathsMedian overall survivalPhase II studyPrimary end pointCooperative group studiesPromising preclinical dataChemotherapy backboneChemotherapy regimensAdverse eventsII studySecondary outcomesMedian timeTreatment armsPreclinical data
2014
Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303
Egloff AM, Lee JW, Langer CJ, Quon H, Vaezi A, Grandis JR, Seethala RR, Wang L, Shin DM, Argiris A, Yang D, Mehra R, Ridge JA, Patel UA, Burtness BA, Forastiere AA. Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303. Clinical Cancer Research 2014, 20: 5041-5051. PMID: 25107914, PMCID: PMC4184913, DOI: 10.1158/1078-0432.ccr-14-0051.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingRadiotherapyRisk FactorsSquamous Cell Carcinoma of Head and NeckTreatment OutcomeConceptsProgression-free survivalOverall survivalLA-SCCHNMaintenance cetuximabAdvanced squamous cell headMedian progression-free survivalTwo-year overall survivalNeck squamous cell carcinomaTumor human papillomavirus (HPV) statusGrade 5 toxicityMedian overall survivalMedian radiotherapy doseMost common gradeCycles of cisplatinHuman papillomavirus (HPV) statusPhase II studySquamous cell headTumor HPV statusLonger overall survivalSquamous cell carcinomaOropharyngeal primaryHPV statusII studyPrimary endpointProtocol treatmentE2208: Randomized phase II study of paclitaxel with or without the anti-IGF-IR antibody cixutumumab (IMC-A12) as second-line treatment for patients with metastatic esophageal or GE junction cancer.
Cohen S, Feng Y, Catalano P, Mitchell E, O'Dwyer P, Lubner S, Fisher G, Mulcahy M, Burtness B, Benson A. E2208: Randomized phase II study of paclitaxel with or without the anti-IGF-IR antibody cixutumumab (IMC-A12) as second-line treatment for patients with metastatic esophageal or GE junction cancer. Journal Of Clinical Oncology 2014, 32: 4020-4020. DOI: 10.1200/jco.2014.32.15_suppl.4020.Peer-Reviewed Original Research
2012
A Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab with or Without Bevacizumab as Frontline Therapy for Metastatic Colorectal Cancer. A Fox Chase Extramural Research Study
Dotan E, Meropol NJ, Burtness B, Denlinger CS, Lee J, Mintzer D, Zhu F, Ruth K, Tuttle H, Sylvester J, Cohen SJ. A Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab with or Without Bevacizumab as Frontline Therapy for Metastatic Colorectal Cancer. A Fox Chase Extramural Research Study. Journal Of Gastrointestinal Cancer 2012, 43: 562-569. PMID: 22294255, PMCID: PMC3400721, DOI: 10.1007/s12029-012-9368-3.Peer-Reviewed Original ResearchConceptsVascular endothelial growth factorMetastatic colorectal cancerPhase II studyEpidermal growth factor receptorDay 1Arm B.II studyOverall survivalArm AColorectal cancerResponse rateMetastatic colorectal cancer patientsDual antibody therapySafety of capecitabineResultsTwenty-three patientsFirst-line treatmentColorectal cancer patientsOverall response rateKRAS mutation statusEndothelial growth factorBevacizumab 7.5Capecitabine 850Cetuximab 400Growth factor receptorOxaliplatin 130
2010
CALGB 80403/ECOG 1206: A randomized phase II study of three standard chemotherapy regimens (ECF, IC, FOLFOX) plus cetuximab in metastatic esophageal and GE junction cancer.
Enzinger P, Burtness B, Hollis D, Niedzwiecki D, Ilson D, Benson A, Mayer R, Goldberg R. CALGB 80403/ECOG 1206: A randomized phase II study of three standard chemotherapy regimens (ECF, IC, FOLFOX) plus cetuximab in metastatic esophageal and GE junction cancer. Journal Of Clinical Oncology 2010, 28: 4006-4006. DOI: 10.1200/jco.2010.28.15_suppl.4006.Peer-Reviewed Original Research
2009
Phase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN)
Mehra R, Sherman E, Ruth K, Litwin S, Sylvester J, Tuttle H, Burtness B, Cohen R, Langer C. Phase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN). Journal Of Clinical Oncology 2009, 27: 6052-6052. DOI: 10.1200/jco.2009.27.15_suppl.6052.Peer-Reviewed Original ResearchPhase II studyResponse rateII studyOverall survivalMetastatic squamous cell cancerRecurrent/metastatic SCCHNRecurrent/metastatic diseaseStage 1Adequate bone marrowGrade 4 anemiaGrade 3 toxicityMedian overall survivalSquamous cell cancerLack of efficacyAdvanced HNSCCKarnofsky PSLA-SCCHNMetastatic SCCHNPrior therapyUnconfirmed PRAlternative regimenDefinitive therapyPrimary endpointRecurrent diseaseSecondary endpoints
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
2006
632 POSTER Randomized phase II study of BMS-247550 (NSC 710428) given daily X 5 days or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: E2301
Burtness B, Manola J, Argiris A, Altieri D, Axelrod R, Forastiere A. 632 POSTER Randomized phase II study of BMS-247550 (NSC 710428) given daily X 5 days or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: E2301. European Journal Of Cancer Supplements 2006, 4: 190-191. DOI: 10.1016/s1359-6349(06)70637-1.Peer-Reviewed Original ResearchA 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
2005
Five-Year Update of an Expanded Phase II Study of Dose-Dense and -Intense Doxorubicin, Paclitaxel and Cyclophosphamide (ATC) in High-Risk Breast Cancer
Abu-Khalaf MM, Windsor S, Ebisu K, Salikooti S, Ananthanarayanan G, Chung GG, DiGiovanna MP, Haffty BG, Abrams M, Farber LR, Hsu AD, Reiss M, Zelterman D, Burtness BA. Five-Year Update of an Expanded Phase II Study of Dose-Dense and -Intense Doxorubicin, Paclitaxel and Cyclophosphamide (ATC) in High-Risk Breast Cancer. Oncology 2005, 69: 372-383. PMID: 16319508, DOI: 10.1159/000089991.Peer-Reviewed Original ResearchConceptsHigh-risk breast cancerBreast cancerAdjuvant therapyLymph nodesCommon grade 3 toxicitiesIpsilateral axillary lymph nodesGrade 3 toxicityGrade 3/4 neutropeniaPhase II studyAxillary lymph nodesPalmar-plantar erythrodysesthesiaDose-denseEligible patientsFeasible regimenFilgrastim supportNeutropenic feverDistant diseaseAxillary nodesDose intensityII studyBC surgerySequential doxorubicinAcute leukemiaMetastatic cancerMedian number
2004
Cisplatin, Fluorouracil, and Leucovorin Induction Chemotherapy Followed by Concurrent Cisplatin Chemoradiotherapy for Organ Preservation and Cure in Patients With Advanced Head and Neck Cancer: Long-Term Follow-Up
Psyrri A, Kwong M, DiStasio S, Lekakis L, Kassar M, Sasaki C, Wilson LD, Haffty BG, Son YH, Ross DA, Weinberger PM, Chung GG, Zelterman D, Burtness BA, Cooper DL. Cisplatin, Fluorouracil, and Leucovorin Induction Chemotherapy Followed by Concurrent Cisplatin Chemoradiotherapy for Organ Preservation and Cure in Patients With Advanced Head and Neck Cancer: Long-Term Follow-Up. Journal Of Clinical Oncology 2004, 22: 3061-3069. PMID: 15284256, DOI: 10.1200/jco.2004.01.108.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBrachytherapyCarcinoma, Squamous CellCisplatinCombined Modality TherapyDrug Administration ScheduleFemaleFluorouracilFollow-Up StudiesHead and Neck NeoplasmsHumansLeucovorinMaleMiddle AgedQuality of LifeRemission InductionSurvival RateTreatment OutcomeConceptsConcurrent cisplatin chemoradiotherapyComplete response rateInduction chemotherapyCisplatin chemoradiotherapyOrgan preservationResponse rateAdvanced headGrade 3Survival rateProgression-free survival ratesNeck squamous cell carcinomaCommon grade 3Courses of cisplatinPartial response ratePhase II studyOverall survival ratePoor functional outcomeSquamous cell carcinomaExternal beam radiotherapyExcellent PFSResectable HNSCCAdvanced diseaseConcurrent chemoradiotherapyPersistent dysphagiaII study