2016
Trabectedin (T)-related liver toxicity: Results of a pharmacokinetic study with T in patients with hepatic dysfunction (OVC1004) and experience from a phase 3 clinical trial (SAR3007).
Calvo E, Azaro A, Dirix L, Huizing M, Senecal F, LoRusso P, Yee L, Keung C, Triantos S, Park Y, Knoblauch R, Parekh T, Demetri G, vonMehren M. Trabectedin (T)-related liver toxicity: Results of a pharmacokinetic study with T in patients with hepatic dysfunction (OVC1004) and experience from a phase 3 clinical trial (SAR3007). Journal Of Clinical Oncology 2016, 34: 11064-11064. DOI: 10.1200/jco.2016.34.15_suppl.11064.Peer-Reviewed Original Research
2014
Early phase I study of the PARP inhibitor veliparib (ABT-888) alone or in combination with carboplatin/paclitaxel (CP) in patients with varying degrees of hepatic or renal dysfunction: A study of the NCI-Organ Dysfunction Working Group (ODG).
Tawbi H, Chu E, Lin Y, Hyman D, Goel S, Rudek M, Dowlati A, LoRusso P, Mulkerin D, Chew H, Kiesel B, Pollice L, Appleman L, Puhalla S, Stoller R, Lee J, Ivy P, Beumer J. Early phase I study of the PARP inhibitor veliparib (ABT-888) alone or in combination with carboplatin/paclitaxel (CP) in patients with varying degrees of hepatic or renal dysfunction: A study of the NCI-Organ Dysfunction Working Group (ODG). Journal Of Clinical Oncology 2014, 32: 2572-2572. DOI: 10.1200/jco.2014.32.15_suppl.2572.Peer-Reviewed Original Research
2011
Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study
Leal T, Remick S, Takimoto C, Ramanathan R, Davies A, Egorin M, Hamilton A, LoRusso P, Shibata S, Lenz H, Mier J, Sarantopoulos J, Mani S, Wright J, Ivy S, Neuwirth R, von Moltke L, Venkatakrishnan K, Mulkerin D. Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study. Cancer Chemotherapy And Pharmacology 2011, 68: 1439-1447. PMID: 21479634, PMCID: PMC3481841, DOI: 10.1007/s00280-011-1637-5.Peer-Reviewed Original ResearchConceptsSevere renal dysfunctionNormal renal functionRenal dysfunctionAdult cancer patientsRenal functionDialysis patientsDose escalationCancer patientsPatient populationNational Cancer Institute Organ Dysfunction Working Group StudyDose of bortezomibImpaired renal functionGeneral patient populationIntravenous bortezomibRenal impairmentCreatinine clearanceModerate dysfunctionMild dysfunctionSevere dysfunctionDose reductionPharmacologic dataPatientsDay 1DysfunctionBortezomib
2010
Phase I study of vorinostat for patients with advanced solid tumors and hepatic dysfunction: An NCI Organ Dysfunction Working Group (ODWG) study (NCI #8057).
Egorin M, Kummar S, Sarantopoulos J, Shibata S, LoRusso P, Yerk M, Lin Y, Ivy S, Belani C, Ramalingam S. Phase I study of vorinostat for patients with advanced solid tumors and hepatic dysfunction: An NCI Organ Dysfunction Working Group (ODWG) study (NCI #8057). Journal Of Clinical Oncology 2010, 28: 2545-2545. DOI: 10.1200/jco.2010.28.15_suppl.2545.Peer-Reviewed Original Research
2004
A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification
Takimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification. Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.14_suppl.2017.Peer-Reviewed Original ResearchA pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification
Takimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification. Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.90140.2017.Peer-Reviewed Original Research