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
A phase II trial of PS-341 (bortezomib) followed by the addition of doxorubicin at progression in incurable adenoid cystic carcinoma of the head and neck: An Eastern Cooperative Oncology Group study
Argiris A, Goldwasser M, Burtness B, Deconti R, Axelrod R, Van Waes C, Forastiere A. A phase II trial of PS-341 (bortezomib) followed by the addition of doxorubicin at progression in incurable adenoid cystic carcinoma of the head and neck: An Eastern Cooperative Oncology Group study. Journal Of Clinical Oncology 2006, 24: 5573-5573. DOI: 10.1200/jco.2006.24.18_suppl.5573.Peer-Reviewed Original ResearchStable diseaseEvaluable ptsNeutropenia 5Cystic carcinomaEastern Cooperative Oncology Group StudyECOG performance status 0Median progression-free survivalGrade 3/4 toxicitiesPerformance status 0Absolute neutrophil countPhase II trialProgression-free survivalTime of progressionAdenoid cystic carcinomaDistant metastatic sitesNF-κB activityAddition of doxorubicinBaseline tumorDiarrhea 5Measurable diseasePrior therapyStatus 0Thrombocytopenia 5Disease stabilizationII trial
2005
Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study
Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA. Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study. Journal Of Clinical Oncology 2005, 23: 8646-8654. PMID: 16314626, DOI: 10.1200/jco.2005.02.4646.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinCross-Over StudiesDose-Response Relationship, DrugDrug HypersensitivityErbB ReceptorsFemaleFollow-Up StudiesHead and Neck NeoplasmsHematologic DiseasesHumansImmunohistochemistryMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalSeverity of Illness IndexSkin DiseasesSurvival AnalysisTime FactorsTreatment OutcomeConceptsProgression-free survivalAddition of cetuximabRecurrent/metastatic squamous cell carcinomaMedian progression-free survivalMetastatic squamous cell carcinomaEpidermal growth factor receptorSquamous cell carcinomaOverall survivalArm BArm AResponse rateEnd pointHazard ratioCell carcinomaCorrelation of EGFREastern Cooperative Oncology Group StudyMetastatic/recurrent headPhase III randomized trialsCetuximab-treated patientsMedian overall survivalObjective response ratePrimary end pointSecondary end pointsClinical end pointsDevelopment of rash