2001
Phase II Evaluation Of Thalidomide In Patients With Metastatic Breast Cancer
Baidas S, Winer E, Fleming G, Harris L, Pluda J, Crawford J, Yamauchi H, Isaacs C, Hanfelt J, Tefft M, Flockhart D, Johnson, Hawkins M, Lippman M, Hayes D. Phase II Evaluation Of Thalidomide In Patients With Metastatic Breast Cancer. Journal Of The Peripheral Nervous System 2001, 6: 65-66. DOI: 10.1046/j.1529-8027.2001.01008-20.x.Peer-Reviewed Original ResearchMetastatic breast cancerWeeks of treatmentProgressive diseaseBreast cancerDose levelsProgressive metastatic breast cancerGrowth factor serum levelsSingle-agent thalidomideFactor serum levelsPhase II evaluationLack of efficacyDifferent patient populationsLow dose levelsAngiogenic growth factorsStable diseaseDry mouthAdverse eventsSkin rashComplete responseSerum levelsPatient populationWeek 16II evaluationGrade 3Patients
2000
Phase II evaluation of thalidomide in patients with metastatic breast cancer.
Baidas S, Winer E, Fleming G, Harris L, Pluda J, Crawford J, Yamauchi H, Isaacs C, Hanfelt J, Tefft M, Flockhart D, Johnson M, Hawkins M, Lippman M, Hayes D. Phase II evaluation of thalidomide in patients with metastatic breast cancer. Journal Of Clinical Oncology 2000, 18: 2710-7. PMID: 10894870, DOI: 10.1200/jco.2000.18.14.2710.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsBreast NeoplasmsDrug Administration ScheduleEndothelial Growth FactorsFemaleFibroblast Growth Factor 2Growth SubstancesHumansLymphokinesMatrix MetalloproteinasesMiddle AgedNeoplasm MetastasisProspective StudiesThalidomideTumor Necrosis Factor-alphaVascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsMetastatic breast cancerWeeks of treatmentProgressive diseaseBreast cancerDose levelsProgressive metastatic breast cancerGrowth factor serum levelsSingle-agent thalidomideFactor serum levelsPhase II evaluationLack of efficacyDifferent patient populationsLow dose levelsAngiogenic growth factorsStable diseaseDry mouthAdverse eventsSkin rashComplete responseSerum levelsPatient populationWeek 16II evaluationGrade 3Patients
1994
Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors.
Rowinsky EK, Noe DA, Trump DL, Winer EP, Lucas VS, Wargin WA, Hohneker JA, Lubejko B, Sartorius SE, Ettinger DS. Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. Journal Of Clinical Oncology 1994, 12: 1754-63. PMID: 8083697, DOI: 10.1200/jco.1994.12.9.1754.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseOral administrationOral formulationOral vinorelbineGrade 3Large first-pass effectLower starting doseSemisynthetic vinca alkaloidChronic oral administrationHepatic blood flowPhase II evaluationPharmacokinetic studyDivided-dose scheduleMaximum plasma concentrationFirst-pass effectSteady-state volumeGelatin capsulesPlasma drug dispositionPharmacologic exposuresPrincipal toxicityStarting doseDose escalationOral dosesOral doseCancer patients