Clinical trial NCT02737709 - References

Non-small Cell Lung Cancer — Paclitaxel Detection in NSCLC Treated With TC Regimen

Citation(s)

•   Augusto C, Pietro M, Cinzia M, Sergio C, Sara C, Luca G, Scaioli V
  Peripheral neuropathy due to paclitaxel: study of the temporal relationships between the therapeutic schedule and the clinical quantitative score (QST) and comparison with neurophysiological findings. J Neurooncol. 2008 Jan;86(1):89-99. Epub 2007 Jul 5.
•   Baldwin SJ, Clarke SE, Chenery RJ
  Characterization of the cytochrome P450 enzymes involved in the in vitro metabolism of rosiglitazone. Br J Clin Pharmacol. 1999 Sep;48(3):424-32.
•   Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, Kumar G, McLeod J, Obach SR, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton SA; Pharmaceutical Research and Manufacturers of America Drug Metabolism/Clinical Pharmacology Technical Working Groups
  The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective. J Clin Pharmacol. 2003 May;43(5):443-69. Review.
•   Dai D, Zeldin DC, Blaisdell JA, Chanas B, Coulter SJ, Ghanayem BI, Goldstein JA
  Polymorphisms in human CYP2C8 decrease metabolism of the anticancer drug paclitaxel and arachidonic acid. Pharmacogenetics. 2001 Oct;11(7):597-607.
•   Freed MI, Allen A, Jorkasky DK, DiCicco RA
  Systemic exposure to rosiglitazone is unaltered by food. Eur J Clin Pharmacol. 1999 Mar;55(1):53-6.
•   Frye RF
  Probing the world of cytochrome P450 enzymes. Mol Interv. 2004 Jun;4(3):157-62. Review.
•   Gianni L, Kearns CM, Giani A, Capri G, Viganó L, Lacatelli A, Bonadonna G, Egorin MJ
  Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol. 1995 Jan;13(1):180-90.
•   Hertz DL, Walko CM, Bridges AS, Hull JH, Herendeen J, Rollins K, Watkins PB, Dees EC
  Pilot study of rosiglitazone as an in vivo probe of paclitaxel exposure. Br J Clin Pharmacol. 2012 Jul;74(1):197-200. doi: 10.1111/j.1365-2125.2012.04165.x.
•   Huizing MT, Giaccone G, van Warmerdam LJ, Rosing H, Bakker PJ, Vermorken JB, Postmus PE, van Zandwijk N, Koolen MG, ten Bokkel Huinink WW, van der Vijgh WJ, Bierhorst FJ, Lai A, Dalesio O, Pinedo HM, Veenhof CH, Beijnen JH
  Pharmacokinetics of paclitaxel and carboplatin in a dose-escalating and dose-sequencing study in patients with non-small-cell lung cancer. The European Cancer Centre. J Clin Oncol. 1997 Jan;15(1):317-29.
•   Huizing MT, Keung AC, Rosing H, van der Kuij V, ten Bokkel Huinink WW, Mandjes IM, Dubbelman AC, Pinedo HM, Beijnen JH
  Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients. J Clin Oncol. 1993 Nov;11(11):2127-35.
•   Jiko M, Yano I, Sato E, Takahashi K, Motohashi H, Masuda S, Okuda M, Ito N, Nakamura E, Segawa T, Kamoto T, Ogawa O, Inui K
  Pharmacokinetics and pharmacodynamics of paclitaxel with carboplatin or gemcitabine, and effects of CYP3A5 and MDR1 polymorphisms in patients with urogenital cancers. Int J Clin Oncol. 2007 Aug;12(4):284-90. Epub 2007 Aug 20.
•   Joerger M, Huitema AD, Richel DJ, Dittrich C, Pavlidis N, Briasoulis E, Vermorken JB, Strocchi E, Martoni A, Sorio R, Sleeboom HP, Izquierdo MA, Jodrell DI, Calvert H, Boddy AV, Hollema H, Féty R, Van der Vijgh WJ, Hempel G, Chatelut E, Karlsson M, Wilkins J, Tranchand B, Schrijvers AH, Twelves C, Beijnen JH, Schellens JH
  Population pharmacokinetics and pharmacodynamics of paclitaxel and carboplatin in ovarian cancer patients: a study by the European organization for research and treatment of cancer-pharmacology and molecular mechanisms group and new drug development group. Clin Cancer Res. 2007 Nov 1;13(21):6410-8.
•   Joerger M, Huitema AD, van den Bongard DH, Schellens JH, Beijnen JH
  Quantitative effect of gender, age, liver function, and body size on the population pharmacokinetics of Paclitaxel in patients with solid tumors. Clin Cancer Res. 2006 Apr 1;12(7 Pt 1):2150-7.
•   Joerger M, Kraff S, Huitema AD, Feiss G, Moritz B, Schellens JH, Beijnen JH, Jaehde U
  Evaluation of a pharmacology-driven dosing algorithm of 3-weekly paclitaxel using therapeutic drug monitoring: a pharmacokinetic-pharmacodynamic simulation study. Clin Pharmacokinet. 2012 Sep 1;51(9):607-17. doi: 10.2165/11634210-000000000-00000.
•   Kobayashi M, Oba K, Sakamoto J, Kondo K, Nagata N, Okabayashi T, Namikawa T, Hanazaki K
  Pharmacokinetic study of weekly administration dose of paclitaxel in patients with advanced or recurrent gastric cancer in Japan. Gastric Cancer. 2007;10(1):52-7. Epub 2007 Feb 23.
•   Kumar N
  Taxol-induced polymerization of purified tubulin. Mechanism of action. J Biol Chem. 1981 Oct 25;256(20):10435-41.
•   Mielke S, Sparreboom A, Behringer D, Mross K
  Paclitaxel pharmacokinetics and response to chemotherapy in patients with advanced cancer treated with a weekly regimen. Anticancer Res. 2005 Nov-Dec;25(6C):4423-7.
•   Mielke S, Sparreboom A, Steinberg SM, Gelderblom H, Unger C, Behringer D, Mross K
  Association of Paclitaxel pharmacokinetics with the development of peripheral neuropathy in patients with advanced cancer. Clin Cancer Res. 2005 Jul 1;11(13):4843-50.
•   Miller AA, Rosner GL, Egorin MJ, Hollis D, Lichtman SM, Ratain MJ
  Prospective evaluation of body surface area as a determinant of paclitaxel pharmacokinetics and pharmacodynamics in women with solid tumors: Cancer and Leukemia Group B Study 9763. Clin Cancer Res. 2004 Dec 15;10(24):8325-31.
•   Mould DR, Fleming GF, Darcy KM, Spriggs D
  Population analysis of a 24-h paclitaxel infusion in advanced endometrial cancer: a gynaecological oncology group study. Br J Clin Pharmacol. 2006 Jul;62(1):56-70.
•   Naik H, Wu JT, Palmer R, McLean L
  The effects of febuxostat on the pharmacokinetic parameters of rosiglitazone, a CYP2C8 substrate. Br J Clin Pharmacol. 2012 Aug;74(2):327-35. doi: 10.1111/j.1365-2125.2012.04182.x.
•   Nakajima M, Fujiki Y, Kyo S, Kanaya T, Nakamura M, Maida Y, Tanaka M, Inoue M, Yokoi T
  Pharmacokinetics of paclitaxel in ovarian cancer patients and genetic polymorphisms of CYP2C8, CYP3A4, and MDR1. J Clin Pharmacol. 2005 Jun;45(6):674-82.
•   Ohtsu T, Sasaki Y, Tamura T, Miyata Y, Nakanomyo H, Nishiwaki Y, Saijo N
  Clinical pharmacokinetics and pharmacodynamics of paclitaxel: a 3-hour infusion versus a 24-hour infusion. Clin Cancer Res. 1995 Jun;1(6):599-606.
•   Sahi J, Black CB, Hamilton GA, Zheng X, Jolley S, Rose KA, Gilbert D, LeCluyse EL, Sinz MW
  Comparative effects of thiazolidinediones on in vitro P450 enzyme induction and inhibition. Drug Metab Dispos. 2003 Apr;31(4):439-46.
•   Sarosy G, Reed E
  Taxol dose intensification and its clinical implications. J Natl Med Assoc. 1993 Jun;85(6):427-31. Review.
•   Sparreboom A, Huizing MT, Boesen JJ, Nooijen WJ, van Tellingen O, Beijnen JH
  Isolation, purification, and biological activity of mono- and dihydroxylated paclitaxel metabolites from human feces. Cancer Chemother Pharmacol. 1995;36(4):299-304.
•   Spratlin J, Sawyer MB
  Pharmacogenetics of paclitaxel metabolism. Crit Rev Oncol Hematol. 2007 Mar;61(3):222-9. Epub 2006 Nov 7. Review.

A Clinical Experience Trial to Detect the Plasma Paclitaxel Drug Concentration in Chinese Non -Small Cell Lung Cancer (NSCLC) Patients Treated With a Paclitaxel Plus Carboplatin (TC) Regimens, and Explore Individualized Treatment Using Pharmacokinetically-guided Dosing Strategy

Details for clinical trial NCT02737709