2006
A phase II clinical and pharmacodynamic study of temsirolimus in advanced neuroendocrine carcinomas
Duran I, Kortmansky J, Singh D, Hirte H, Kocha W, Goss G, Le L, Oza A, Nicklee T, Ho J, Birle D, Pond G, Arboine D, Dancey J, Aviel-Ronen S, Tsao M, Hedley D, Siu L. A phase II clinical and pharmacodynamic study of temsirolimus in advanced neuroendocrine carcinomas. British Journal Of Cancer 2006, 95: 1148-1154. PMID: 17031397, PMCID: PMC2360568, DOI: 10.1038/sj.bjc.6603419.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsCarcinoid TumorCarcinoma, NeuroendocrineDisease ProgressionExanthemaFatigueFemaleFollow-Up StudiesHumansHyperglycemiaInfusions, IntravenousMaleMiddle AgedPancreatic NeoplasmsPhosphorylationProtein KinasesProto-Oncogene Proteins c-aktRibosomal Protein S6SirolimusSurvival AnalysisTOR Serine-Threonine KinasesTreatment OutcomeConceptsAdvanced neuroendocrine carcinomaNeuroendocrine carcinomaAdverse eventsOverall survivalFrequent drug-related adverse eventsDrug-related adverse eventsRash/desquamationTreat response ratePhase II studyPercentage of patientsHigher baseline levelsII studyWeekly dosesNeuroendocrine tumorsTumor responsePharmacodynamic analysisPharmacodynamic studiesTumor biopsiesTemsirolimusResponse rateBaseline levelsPatientsPathway downregulationArchival specimensPhosphorylation of S6
1995
Quality of Life in Phase II Trials: a Study of Methodology and Predictive Value in Patients With Advanced Breast Cancer Treated With Paclitaxel Plus Granulocyte Colony-Stimulating Factor
Seidman A, Portenoy R, Yao T, Lepore J, Mont E, Kortmansky J, Onetto N, Ren L, Grechko J, Beltangady M, Usakewicz J, Southrada M, Houston C, McCabe M, Salvaggio R, Thaler H, Norton L. Quality of Life in Phase II Trials: a Study of Methodology and Predictive Value in Patients With Advanced Breast Cancer Treated With Paclitaxel Plus Granulocyte Colony-Stimulating Factor. Journal Of The National Cancer Institute 1995, 87: 1316-1322. PMID: 7544834, DOI: 10.1093/jnci/87.17.1316.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerQuality of lifePhase II clinical trialStandard prognostic factorsGranulocyte colony-stimulating factorTumor responseBreast cancerColony-stimulating factorPrognostic factorsLife scoresSerial assessmentClinical trialsLife instrumentsGrade 4 nonhematologic toxicityLife assessmentRecombinant human granulocyte colony-stimulating factorStandard prognostic indicatorsAdvanced breast cancerPhase II trialExtent of diseaseMajority of patientsPartial tumor responseExtensive prior chemotherapyHuman granulocyte colony-stimulating factorBase-line scores