2021
A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC)
Yardley DA, Young RR, Adelson KB, Silber AL, Najera JE, Daniel DB, Peacock N, Finney L, Hoekstra SJ, Shastry M, Hainsworth JD, Burris HA. A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC). Clinical Breast Cancer 2021, 22: 269-278. PMID: 34824002, DOI: 10.1016/j.clbc.2021.10.011.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerCohort 2Cohort 1Breast cancerAndrogen biosynthesisAmylase/lipaseLimited clinical activityPrior chemotherapy regimenPrior chemotherapy regimensMedian treatment durationNausea/vomitingChemotherapy regimenChemotherapy regimensPrimary endpointObjective responseOverall survivalFemale patientsAndrogen receptorClinical activityGrade 3Targetable pathwaysPatientsTherapeutic targetAR modulationTreatment duration
2015
First-in-human multicenter phase I study of BMS-936561 (MDX-1203), an antibody-drug conjugate targeting CD70
Owonikoko TK, Hussain A, Stadler WM, Smith DC, Kluger H, Molina AM, Gulati P, Shah A, Ahlers CM, Cardarelli PM, Cohen LJ. First-in-human multicenter phase I study of BMS-936561 (MDX-1203), an antibody-drug conjugate targeting CD70. Cancer Chemotherapy And Pharmacology 2015, 77: 155-162. PMID: 26576779, DOI: 10.1007/s00280-015-2909-2.Peer-Reviewed Original ResearchConceptsAdverse eventsECOG performance status 0Active drug levelsGrade 3 hypersensitivityMulticenter phase IPerformance status 0Prior chemotherapy regimensFrequent adverse eventsDose-proportional increaseAdvanced ccRCCEligible patientsStatus 0Chemotherapy regimensDisease stabilizationExpansion cohortDose escalationMedian agePK analysisDrug levelsPharmacokinetic samplesB-NHLTitration designHigh doseDose levelsPatients
2014
A Phase II study of bevacizumab in combination with trastuzumab and docetaxel in HER2 positive metastatic breast cancer
Zhao M, Pan X, Layman R, Lustberg M, Mrozek E, Macrae E, Wesolowski R, Carothers S, Puhalla S, Shapiro C, Ramaswamy B. A Phase II study of bevacizumab in combination with trastuzumab and docetaxel in HER2 positive metastatic breast cancer. Investigational New Drugs 2014, 32: 1285-1294. PMID: 24894652, PMCID: PMC4303337, DOI: 10.1007/s10637-014-0122-5.Peer-Reviewed Original ResearchConceptsProgression-free survivalLeft ventricular ejection fractionClinical benefit rateHER2-positive MBCObjective response rateComplete responsePartial responseBreast cancerStable diseaseFree survivalGrade 3HER2-positive metastatic breast cancerResponse rateAdditional overall survival benefitsMedian progression-free survivalMetastatic breast cancer patientsPositive metastatic breast cancerVascular epithelial growth factorCommon grade 3Cycles of bevacizumabGrade 2 hypertensionMethods Eligible patientsPrior chemotherapy regimensCombination of bevacizumabHand-foot syndrome
2012
Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics
Mayer EL, Isakoff SJ, Klement G, Downing SR, Chen WY, Hannagan K, Gelman R, Winer EP, Burstein HJ. Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics. Breast Cancer Research And Treatment 2012, 136: 169-178. PMID: 23001754, PMCID: PMC5472381, DOI: 10.1007/s10549-012-2256-5.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, MetronomicAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBlood PlateletsBreast NeoplasmsCombined Modality TherapyCyclophosphamideDrug-Related Side Effects and Adverse ReactionsFemaleGene Expression Regulation, NeoplasticHumansMethotrexateMiddle AgedNeoplasm StagingNeovascularization, PathologicPiperidinesPlatelet Factor 4ProteomicsQuinazolinesVascular Endothelial Growth Factor AVascular Endothelial Growth Factor Receptor-1ConceptsMetastatic breast cancerBreast cancerMetronomic chemotherapyAntiangiogenic therapyCombination antiangiogenic therapyDose-escalation cohortsPrior chemotherapy regimensResponse-evaluable patientsAdvanced breast cancerModest clinical activityDose-limiting toxicityPhase 1 studyPhase 1 trialVascular endothelial growth factorPlatelet factor 4Platelet-associated proteinsEndothelial growth factorEligible patientsLFT abnormalitiesMetronomic cyclophosphamideStable diseaseChemotherapy regimensPrimary endpointSecondary endpointsPartial responseResults of a global phase II study with crizotinib in advanced ALK -positive non-small cell lung cancer (NSCLC).
Kim D, Ahn M, Shi Y, De Pas T, Yang P, Riely G, Crinò L, Evans T, Liu X, Han J, Salgia R, Moro-Sibilot D, Ou S, Gettinger S, Wu Y, Lanzalone S, Polli A, Iyer S, Shaw A. Results of a global phase II study with crizotinib in advanced ALK -positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2012, 30: 7533-7533. DOI: 10.1200/jco.2012.30.15_suppl.7533.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced ALK-positive non-small cell lung cancerALK-positive non-small cell lung cancerPatient-reported symptomsTumor responseFrequent treatment-related AEsECOG PS 0Efficacy of crizotinibPrior chemotherapy regimensTreatment-related AEsTreatment-related SAEsDisease control rateMedian treatment durationPhase II studyFavorable tolerability profileMajority of patientsCell lung cancerEnd of treatmentEORTC QLQ-C30Standard of careALK gene rearrangementHigh response rateFebrile neutropeniaLC-13Median PFS
2009
A phase II study of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine and ovarian cancers
Gupta D, Owers RL, Kim M, Kuo DY, Huang GS, Shahabi S, Goldberg GL, Einstein MH. A phase II study of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine and ovarian cancers. Gynecologic Oncology 2009, 113: 327-330. PMID: 19307014, PMCID: PMC4451225, DOI: 10.1016/j.ygyno.2009.02.018.Peer-Reviewed Original ResearchConceptsWeekly topotecanClinical benefitOverall survivalOvarian cancerGrade 3 non-hematologic toxicityKaplan-Meier statistical methodNon-hematologic toxicitiesPrior chemotherapy regimensCycles of chemotherapyGrade 3 toxicityMedian overall survivalPhase II studyPhase II trialMajority of patientsEpithelial ovarian cancerOverall response ratePlatinum-resistant tumorsDose delaysEligible patientsRustin criteriaChemotherapy regimensII trialUnacceptable toxicityII studyMedian durationA phase I open-label study using lenalidomide and docetaxel in castration- resistant prostate cancer
Petrylak D, Resto-Garces K, Tibyan M, Mohile S. A phase I open-label study using lenalidomide and docetaxel in castration- resistant prostate cancer. Journal Of Clinical Oncology 2009, 27: 5156-5156. DOI: 10.1200/jco.2009.27.15_suppl.5156.Peer-Reviewed Original ResearchMeasurable diseaseDay 1Dose levelsPhase I open-label studyCastration-resistant prostate cancerGrade 3 neutropeniaGrade 3/4 toxicitiesGrade 4 neutropeniaMedian baseline PSAOpen-label studyPost-treatment PSAPrior chemotherapy regimensMetastatic pulmonary nodulesDeep venous thrombosisFurther dose escalationPhase I trialEfficacy of docetaxelNear complete resolutionCycle 1Derivative of thalidomideAntiandrogen withdrawalNCI trialProphylactic anticoagulationTreatment PSAChemotherapy regimensAssessment of two dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancer (GC): Interim results of a multicenter phase II study
Jhawer M, Kindler H, Wainberg Z, Ford J, Kunz P, Tang L, McCallum S, Kallender H, Shah M. Assessment of two dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancer (GC): Interim results of a multicenter phase II study. Journal Of Clinical Oncology 2009, 27: 4502-4502. DOI: 10.1200/jco.2009.27.15_suppl.4502.Peer-Reviewed Original ResearchMetastatic gastric cancerPhase II studyGastric cancerStable diseaseAdverse eventsCMET amplificationEvaluable ptsII studyDosing schedulesGrade 5 adverse eventsMulticenter phase II studyAdequate organ functionECOG PS 0Prior chemotherapy regimensTreatment tumor biopsiesAntitumor activityDaily dosing schedulePrimary study endpointMinimal antitumor activityAttractive therapeutic targetCMET pathwayLFT abnormalitiesMeasurable diseaseTreatment biopsiesChemotherapy regimensA phase I study of vandetanib and metronomic chemotherapy in advanced breast cancer.
Mayer E, Isakoff S, Hannagan K, Savoie J, Beckman J, Klement G, Gelman R, Winer E, Burstein H. A phase I study of vandetanib and metronomic chemotherapy in advanced breast cancer. Cancer Research 2009, 69: 906. DOI: 10.1158/0008-5472.sabcs-906.Peer-Reviewed Original ResearchAdvanced breast cancerDose-escalation cohortsAbnormal hepatic functionVascular endothelial growth factorBreast cancerMetronomic chemotherapyHepatic functionContinuous low-dose oral cyclophosphamideLow-dose oral cyclophosphamideSequential dose-escalation cohortsStage IV breast cancerOral tyrosine kinase inhibitorGrade 3 eventsOral combination therapyPrior chemotherapy regimensStable brain metastasesModest clinical activityAnti-angiogenic treatmentTyrosine kinase inhibitorsEndothelial growth factorEpidermal growth factor receptorEligible patientsGrowth factor receptorMeasurable diseaseModerate hypertension
2008
VEGF as a Marker for Outcome Among Advanced Breast Cancer Patients Receiving anti-VEGF Therapy with Bevacizumab and Vinorelbine Chemotherapy
Burstein HJ, Chen YH, Parker LM, Savoie J, Younger J, Kuter I, Ryan PD, Garber JE, Chen H, Campos SM, Shulman LN, Harris LN, Gelman R, Winer EP. VEGF as a Marker for Outcome Among Advanced Breast Cancer Patients Receiving anti-VEGF Therapy with Bevacizumab and Vinorelbine Chemotherapy. Clinical Cancer Research 2008, 14: 7871-7877. PMID: 19047116, DOI: 10.1158/1078-0432.ccr-08-0593.Peer-Reviewed Original ResearchConceptsAdvanced breast cancer patientsRefractory breast cancerBreast cancer patientsBreast cancerPlasma VEGFCancer patientsTreatment outcomesSide effectsAnti-vascular endothelial growth factor therapyAdequate end-organ functionEndothelial growth factor therapyImportant new treatment modalityTumor hormone receptor statusMonoclonal anti-VEGF antibodyPrior chemotherapy regimensEnd-organ functionHormone receptor statusAnti-VEGF therapyMetastatic breast cancerGrowth factor therapyNew treatment modalitiesWarrants further evaluationAnti-VEGF antibodyBaseline VEGFEligible patientsPhase II trial of romidepsin (NSC-630176) in previously treated colorectal cancer patients with advanced disease: a Southwest Oncology Group study (S0336)
Whitehead R, Rankin C, Hoff P, Gold P, Billingsley K, Chapman R, Wong L, Ward J, Abbruzzese J, Blanke C. Phase II trial of romidepsin (NSC-630176) in previously treated colorectal cancer patients with advanced disease: a Southwest Oncology Group study (S0336). Investigational New Drugs 2008, 27: 469. PMID: 18941712, PMCID: PMC3024913, DOI: 10.1007/s10637-008-9190-8.Peer-Reviewed Original ResearchConceptsMetastatic colorectal cancerColorectal cancerPerformance statusSouthwest Oncology Group studyAdequate bone marrowCombination of romidepsinPrior chemotherapy regimenPrior chemotherapy regimensSignificant cardiac diseaseHuman tumor xenograft modelsAdvanced colorectal cancerPhase II trialColorectal cancer patientsGroup of patientsTreatment of patientsTumor growth inhibitionTumor xenograft modelHistone deacetylase inhibitorsEligible patientsPrior chemotherapyPrior regimensStable diseaseAdvanced diseaseChemotherapy regimenChemotherapy regimens
2006
ORAL GIMATECAN IN WOMEN WITH PROGRESSING OR RECURRING ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE AND PERITONEAL CANCERS
Pecorelli S, Ray-Coquard I, Colombo N, Parma G, Tognon G, Katsaros D, Lhomme C, Lissoni A, Vermorken J, du Bois A, Poveda A, Frigerio L, Guastalla J. ORAL GIMATECAN IN WOMEN WITH PROGRESSING OR RECURRING ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE AND PERITONEAL CANCERS. International Journal Of Gynecological Cancer 2006, 16: 650. DOI: 10.1136/ijgc-00009577-200610001-00177.Peer-Reviewed Original ResearchProgression-free intervalFallopian tubeOral topoisomerase I inhibitorAcceptable level of toxicityPrior chemotherapy regimensOverall response rateTopoisomerase I inhibitorEpithelial ovarianGCIG criteriaPeritoneal cancerCA-125Chemotherapy regimensGastrointestinal toxicityMedian ageCT scanSingle agentGimatecanAntitumor activityResponse rateConsecutive daysG3/4CA125Disease responseMonthsPatientsRebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules
Burstein HJ, Overmoyer B, Gelman R, Silverman P, Savoie J, Clarke K, Dumadag L, Younger J, Ivy P, Winer EP. Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules. Investigational New Drugs 2006, 25: 161-164. PMID: 16969707, DOI: 10.1007/s10637-006-9007-6.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerDifferent treatment schedulesBreast cancerTreatment scheduleAdjuvant chemotherapyArm 2Arm 1Response rateAnthracycline-based adjuvant chemotherapyRefractory advanced breast cancerRandomized phase II trialPrior chemotherapy regimensRefractory breast cancerModest clinical activityPhase II trialPrimary study endpointMetastatic breast cancerCentral venous accessAnemia 5Eligible patientsMeasurable diseaseNausea/Prior chemotherapyStable diseaseChemotherapy regimensPhase II trial of depsipeptide (NSC-630176) in colorectal cancer patients who have received either one or two prior chemotherapy regimens for metastatic or locally advanced, unresectable disease: A Southwest Oncology Group study
Whitehead R, McCoy S, Wollner I, Wong L, Harker W, Hoff P, Gold P, Billingsley K, Blanke C. Phase II trial of depsipeptide (NSC-630176) in colorectal cancer patients who have received either one or two prior chemotherapy regimens for metastatic or locally advanced, unresectable disease: A Southwest Oncology Group study. Journal Of Clinical Oncology 2006, 24: 3598-3598. DOI: 10.1200/jco.2006.24.18_suppl.3598.Peer-Reviewed Original ResearchPrior chemotherapy regimensAdvanced colorectal cancerPhase II trialColorectal cancerEligible patientsChemotherapy regimensII trialPerformance statusSouthwest Oncology Group studyCommon grade 2Prior chemotherapy regimenZubrod performance statusMetastatic colorectal cancerMonths overall survivalColorectal cancer patientsSerum magnesium levelsSignificant anti-tumor activityKaplan-Meier estimatesAdditional active agentsAnti-tumor activityHistone deacetylase inhibitorsMurine model systemBaseline labsMeasurable diseasePrior regimensA phase I open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide with every three week docetaxel in subjects with androgen independent prostate cancer
Moss R, Shelton G, Melia J, Mohile S, Petrylak D. A phase I open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide with every three week docetaxel in subjects with androgen independent prostate cancer. Journal Of Clinical Oncology 2006, 24: 14618-14618. DOI: 10.1200/jco.2006.24.18_suppl.14618.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerIndependent prostate cancerMeasurable diseaseProstate cancerSerum prostate-specific antigen levelProstate-specific antigen levelDose escalation schedulePrior chemotherapy regimensEvidence of progressionFurther dose escalationPhase I trialSpecific antigen levelsEfficacy of docetaxelDerivative of thalidomideAntiandrogen withdrawalL1 patientsPalliative RTPo bidStable diseaseChemotherapy regimensMedian PSARECIST criteriaEscalation studySerum PSABone metastases
2005
Clinically Meaningful Improvement in Symptoms and Quality of Life for Patients With Non-Small-Cell Lung Cancer Receiving Gefitinib in a Randomized Controlled Trial
Cella D, Herbst RS, Lynch TJ, Prager D, Belani CP, Schiller JH, Heyes A, Ochs JS, Wolf MK, Kay AC, Kris MG, Natale RB. Clinically Meaningful Improvement in Symptoms and Quality of Life for Patients With Non-Small-Cell Lung Cancer Receiving Gefitinib in a Randomized Controlled Trial. Journal Of Clinical Oncology 2005, 23: 2946-2954. PMID: 15699477, DOI: 10.1200/jco.2005.05.153.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDouble-Blind MethodEndpoint DeterminationFemaleGefitinibHealth StatusHumansLung NeoplasmsMaleMiddle AgedQuality of LifeQuinazolinesSensitivity and SpecificitySurvival AnalysisConceptsLung Cancer SubscaleSymptom improvementTumor responseQuality of lifeCancer Therapy-Lung (FACT-L) questionnairePivotal phase II trialMedian overall survival timeCoprimary end pointsPrior chemotherapy regimensProtocol-specified analysisSymptom improvement ratePhase II trialBetter overall survivalCell lung cancerOverall survival timeGefitinib 250Radiographic regressionChemotherapy regimensStable diseaseII trialMost patientsOverall survivalRadiographic responseSymptomatic patientsNSCLC patients
2004
Failure of Higher-Dose Paclitaxel to Improve Outcome in Patients With Metastatic Breast Cancer: Cancer and Leukemia Group B Trial 9342
Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN, Michaelson RA, Kirshner JA, Fleming GF, Perry MC, Graham ML, Sharp SA, Keresztes R, Henderson IC, Hudis C, Muss H, Norton L. Failure of Higher-Dose Paclitaxel to Improve Outcome in Patients With Metastatic Breast Cancer: Cancer and Leukemia Group B Trial 9342. Journal Of Clinical Oncology 2004, 22: 2061-2068. PMID: 15169793, DOI: 10.1200/jco.2004.08.048.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerQuality of lifeOptimal doseResponse rateSignificant dose-response relationshipHigh-dose armPrior chemotherapy regimensHigh-dose therapySymptom assessment questionnaireCycles of treatmentSelf-administered qualitySignificant differencesDose-response relationshipChemotherapy regimensDose therapyHematologic toxicityDose armAssessment QuestionnaireHigh dosesMultivariate analysisSignificant associationInfusionCancerRegimens
2003
A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer
Massarelli E, Andre F, Liu DD, Lee JJ, Wolf M, Fandi A, Ochs J, Le Chevalier T, Fossella F, Herbst RS. A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer. Lung Cancer 2003, 39: 55-61. PMID: 12499095, DOI: 10.1016/s0169-5002(02)00308-2.Peer-Reviewed Original ResearchConceptsMedian overall survival timePrior chemotherapy regimensSecond-line treatmentCell lung cancerOverall survival timeChemotherapy regimensLung cancerChemotherapy agentsRetrospective analysisSurvival timeDisease control rateFourth-line chemotherapyFourth-line treatmentOverall performance statusSecond-line therapyStage III diseaseStage IV diseaseOutcomes of patientsDays of chemotherapyFirst-line treatmentLine of treatmentEuropean cancer centersNovel therapy approachesRecurrent NSCLCAdvanced NSCLC
2002
The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma
Herbst RS, Khuri FR, Lu C, Liu DD, Fossella FV, Glisson BS, Pisters KM, Shin DM, Papadimitrakopoulou VA, Kurie JM, Blumenschein G, Kies MS, Zinner R, Jung MS, Lu R, Lee JJ, Munden RF, Hong WK, Lee JS. The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma. Cancer 2002, 95: 340-353. PMID: 12124835, DOI: 10.1002/cncr.10629.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntimetabolites, AntineoplasticAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBiological TherapyCarcinoma, Non-Small-Cell LungCombined Modality TherapyDeoxycytidineDisease ProgressionFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedSurvival RateVinblastineVinorelbineConceptsNonsmall cell lung carcinomaYear survival rateAdvanced nonsmall cell lung carcinomaThird-line therapyPhase II trialMedian survival timeCell lung carcinomaGrade 3Survival rateSignificant myelosuppressionStable diseaseII trialLung carcinomaSurvival timeStage IV nonsmall cell lung carcinomaDay 1Day 15Formal phase II trialCurrent phase II trialDose of vinorelbineGemcitabine/vinorelbineGrade 3 granulocytopeniaMedian performance statusMinimal grade 3Prior chemotherapy regimens
2001
A phase II study of STEALTH cisplatin (SPI-77) in patients with advanced non-small cell lung cancer
Kim E, Lu C, Khuri F, Tonda M, Glisson B, Liu D, Jung M, Hong W, Herbst R. A phase II study of STEALTH cisplatin (SPI-77) in patients with advanced non-small cell lung cancer. Lung Cancer 2001, 34: 427-432. PMID: 11714540, DOI: 10.1016/s0169-5002(01)00278-1.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPhase II studyPlatinum-based chemotherapyCell lung cancerII studyLung cancerStage IV non-small cell lung cancerAdvanced non-small cell lung cancerGrade 3 nonhematological toxicitiesMedian Karnofsky performance statusPrior platinum-based chemotherapyPhase ICisplatin-based regimensPrior chemotherapy regimensGrade 4 toxicityKarnofsky performance statusPopulation of patientsDose-related toxicityNonhematological toxicitiesStable diseaseChemotherapy regimensRenal insufficiencyStage IIIBMedian survivalPerformance status
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