2005
Proteasome Inhibition With Bortezomib (PS-341): A Phase I Study With Pharmacodynamic End Points Using a Day 1 and Day 4 Schedule in a 14-Day Cycle
Hamilton AL, Eder JP, Pavlick AC, Clark JW, Liebes L, Garcia-Carbonero R, Chachoua A, Ryan DP, Soma V, Farrell K, Kinchla N, Boyden J, Yee H, Zeleniuch-Jacquotte A, Wright J, Elliott P, Adams J, Muggia FM. Proteasome Inhibition With Bortezomib (PS-341): A Phase I Study With Pharmacodynamic End Points Using a Day 1 and Day 4 Schedule in a 14-Day Cycle. Journal Of Clinical Oncology 2005, 23: 6107-6116. PMID: 16135477, DOI: 10.1200/jco.2005.01.136.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityDay 1Main dose-limiting toxicityPhase IGrade 3 thrombocytopeniaPhase II doseCell lung cancerPharmacodynamic end pointsRenal cell carcinomaProteasome activityNovel antineoplastic agentPartial responseCell carcinomaLung cancerToxicity profileWeek scheduleAntitumor effectsDose levelsPatientsSolid tumorsTotal doseHigh dosesTotal dosesNeurotoxic agentsBaseline activity
1989
A phase I clinical and pharmacokinetic study of carboplatin and autologous bone marrow support.
Shea TC, Flaherty M, Elias A, Eder JP, Antman K, Begg C, Schnipper L, Frei E, Henner WD. A phase I clinical and pharmacokinetic study of carboplatin and autologous bone marrow support. Journal Of Clinical Oncology 1989, 7: 651-61. PMID: 2651580, DOI: 10.1200/jco.1989.7.5.651.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseAutologous bone marrow reinfusionAutologous bone marrow supportBone marrow reinfusionBone marrow supportMarrow reinfusionMarrow supportSystemic clearancePhase IConsiderable dose escalationRecurrent ovarian cancerPharmacokinetic studySevere ototoxicityToxicity consistingRenal dysfunctionDose escalationReversible hepatotoxicityContinuous infusionOvarian cancerActive drugHigh dosesLow dosesCarboplatinPatientsDoses