2012
Phase I trial of ixabepilone administered as three oral doses each separated by 6 hours every 3 weeks in patients with advanced solid tumors
Kunz PL, He AR, Colevas AD, Pishvaian MJ, Hwang JJ, Clemens PL, Messina M, Kaleta R, Abrahao F, Sikic BI, Marshall JL. Phase I trial of ixabepilone administered as three oral doses each separated by 6 hours every 3 weeks in patients with advanced solid tumors. Investigational New Drugs 2012, 30: 2364-2370. PMID: 22331549, PMCID: PMC3703248, DOI: 10.1007/s10637-012-9800-3.Peer-Reviewed Original ResearchConceptsNeutropenic sepsisGrade 4 febrile neutropeniaDoses of ixabepiloneAdvanced solid tumorsExcellent performance statusPhase I trialSerial plasma samplesPlasma drug concentrationsRefractory advanced cancersHigh inter-individual variabilityFebrile neutropeniaPerformance statusI trialMedian ageAdvanced cancerInter-individual variabilityOral dosesSafety profileCohort 2Cohort 1Cohort 3PK variabilityOral formulationIxabepilonePatients
2008
Phase I trial of preoperative cetuximab in combination with oxaliplatin, capecitabine, and radiation therapy for locally advanced rectal cancer
Cabebe E, Kuo T, Koong A, Welton M, Shelton A, Kunz P, Ford J, Sikic B, Kaiser H, Rogers J, Fisher G. Phase I trial of preoperative cetuximab in combination with oxaliplatin, capecitabine, and radiation therapy for locally advanced rectal cancer. Journal Of Clinical Oncology 2008, 26: 15019-15019. DOI: 10.1200/jco.2008.26.15_suppl.15019.Peer-Reviewed Original Research