The absolute bioavailability of oral vinorelbine in patients with solid tumors.

作者: Richard M. Lush , Jeannine S. McCune , Leticia Tetteh , John A. Thompson , J. J. Mahany

DOI: 10.1007/S00280-005-1025-0

关键词:

摘要: Due to advances in the methods used quantitate vinorelbine, this study was conducted characterize fully bioavailability of an oral dosage form vinorelbine. Twenty-seven eligible patients with solid tumors were enrolled onto and treated a randomized crossover design receive either 70 mg/m2 orally or 30 intravenously followed by alternative treatment one week later. Vinorelbine administered as soft-gelatin capsule. Pharmacokinetic sampling carried out for 7 days following each dose. Whole blood vinorelbine concentrations measured using sensitive LC/MS/MS method. The data from excluded if they vomited within 3 h after Results: Three subjects removed first dose due safety reasons. Of remaining 24 subjects, five experienced vomiting dosing. Total body clearance calculated intravenous 43.65 L/h (±10.9) terminal half-life estimated be 49 h. Using complete 19 mean absolute formulation 33% (±18%). In conclusion we have characterized pharmacokinetics both over administration determined 33%.

参考文章(21)
C. Belani, E. E. Vokes, J. Craig, J. Hohneker, R. Rosenberg, S. Jones, M. Jahanzeb, R. Gralla, J. Bigley, Tuttle, Gralla, O'Rourke, Moinpour, Crawford, Viallet, Oral vinorelbine (Navelbine) in the treatment of advanced non-small cell lung cancer: A preliminary report Seminars in Oncology. ,vol. 21, pp. 35- 41 ,(1994)
T Conroy, P L Etienne, A Adenis, D J Wagener, B Paillot, E François, L Bedenne, J H Jacob, J F Seitz, H Bleiberg, C Van Pottelsberghe, M Van Glabbeke, F M Delgado, S Merle, J Wils, Phase II trial of vinorelbine in metastatic squamous cell esophageal carcinoma. European Organization for Research and Treatment of Cancer Gastrointestinal Treat Cancer Cooperative Group. Journal of Clinical Oncology. ,vol. 14, pp. 164- 170 ,(1996) , 10.1200/JCO.1996.14.1.164
E K Rowinsky, D A Noe, D L Trump, E P Winer, V S Lucas, W A Wargin, J A Hohneker, B Lubejko, S E Sartorius, D S Ettinger, Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. Journal of Clinical Oncology. ,vol. 12, pp. 1754- 1763 ,(1994) , 10.1200/JCO.1994.12.9.1754
Robert A. Burger, Philip J. DiSaia, James A. Roberts, Mark O'Rourke, David M. Gershenson, Howard D. Homesley, Stuart M. Lichtman, Willard Barnes, David H. Moore, Bradley J. Monk, Phase II trial of vinorelbine in recurrent and progressive epithelial ovarian cancer Gynecologic Oncology. ,vol. 72, pp. 148- 153 ,(1999) , 10.1006/GYNO.1998.5243
Peter Sørensen, Morten Høyer, Anders Jakobsen, Henric Malmström, Hanne Havsteen, Kamma Bertelsen, Phase II Study of Vinorelbine in the Treatment of Platinum-Resistant Ovarian Carcinoma Gynecologic Oncology. ,vol. 81, pp. 58- 62 ,(2001) , 10.1006/GYNO.2000.6089
David Khayat, Olivier Rixe, René Brunet, Alain Goupil, Roland Bugat, Jean-Luc Harousseau, Norbert Ifrah, Christian Puozzo, None, Pharmacokinetic linearity of i.v. vinorelbine from an intra-patient dose escalation study design. Cancer Chemotherapy and Pharmacology. ,vol. 54, pp. 193- 205 ,(2004) , 10.1007/S00280-004-0794-1
Mario Airoldi, Fulvia Pedani, Giovanni Succo, Anna Maria Gabriele, Riccardo Ragona, Sara Marchionatti, Cesare Bumma, Phase II randomized trial comparing vinorelbine versus vinorelbine plus cisplatin in patients with recurrent salivary gland malignancies Cancer. ,vol. 91, pp. 541- 547 ,(2001) , 10.1002/1097-0142(20010201)91:3<541::AID-CNCR1032>3.0.CO;2-Y
R. Sorio, I. Robieux, E. Galligioni, A. Freschi, A.M. Colussi, D. Crivellari, S. Saracchini, S. Monfardini, Pharmacokinetics and tolerance of vinorelbine in elderly patients with metastatic breast cancer European Journal of Cancer. ,vol. 33, pp. 301- 303 ,(1997) , 10.1016/S0959-8049(96)00426-1