Phase II Clinical Trial of the Epothilone B Analog, Ixabepilone, in Patients With Non Small-Cell Lung Cancer Whose Tumors Have Failed First-Line Platinum-Based Chemotherapy

作者: Johan Vansteenkiste , Primo N. Lara , Thierry Le Chevalier , Jean-Luc Breton , Philip Bonomi

DOI: 10.1200/JCO.2006.09.7097

关键词:

摘要: Purpose Ixabepilone is the first in a new class of antineoplastic agents, epothilones and their analogs. This international, randomized, phase II trial assessed two administration schedules ixabepilone as second-line therapy patients with non–small-cell lung cancer (NSCLC). Patients Methods had experienced disease progression after one prior cisplatin- or carboplatin-based chemotherapy regimen. was administered single 32 mg/m2 3-hour infusion (77 patients; arm A) 6 1-hour daily for 5 consecutive days (69 B) 3-week cycle. Results The intent-to-treat objective response rate 14.3% A 11.6% B. Median duration 8.7 months (95% CI, 5.3 to 9.5 months) 9.6 6.1 19.7 time 2.1 1.4 2.8 1.5 survival 8.3 5.8 11.5 mon...

参考文章(22)
Christophe A Dooms, Johan F Vansteenkiste, Treatment of patients with advanced non-small cell lung cancer American Journal of Cancer. ,vol. 3, pp. 281- 290 ,(2004) , 10.2165/00024669-200403050-00002
Frank V. Fossella, Russell DeVore, Ronald N. Kerr, Jeffrey Crawford, Ronald R. Natale, Frank Dunphy, Leonard Kalman, Vincent Miller, Jin Soo Lee, Melvin Moore, David Gandara, Daniel Karp, Everett Vokes, Mark Kris, Yong Kim, Francis Gamza, Luz Hammershaimb, , Randomized Phase III Trial of Docetaxel Versus Vinorelbine or Ifosfamide in Patients With Advanced Non–Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy Regimens Journal of Clinical Oncology. ,vol. 18, pp. 2354- 2362 ,(2000) , 10.1200/JCO.2000.18.12.2354
E. L. Kaplan, Paul Meier, Nonparametric Estimation from Incomplete Observations Springer Series in Statistics. ,vol. 53, pp. 319- 337 ,(1992) , 10.1007/978-1-4612-4380-9_25
Robert P. Whitehead, Sheryl McCoy, Saul E. Rivkin, Howard M. Gross, Marcel E. Conrad, Gary C. Doolittle, Robert A. Wolff, J. Wendall Goodwin, Shaker R. Dakhil, James L. Abbruzzese, A Phase II trial of epothilone B analogue BMS-247550 (NSC #710428) ixabepilone, in patients with advanced pancreas cancer: A Southwest Oncology Group study Investigational New Drugs. ,vol. 24, pp. 515- 520 ,(2006) , 10.1007/S10637-006-8440-X
Jame Abraham, Manish Agrawal, Susan Bakke, Ann Rutt, Maureen Edgerly, Frank M. Balis, Brigitte Widemann, Louis Davis, Bharat Damle, Daryl Sonnichsen, David Lebwohl, Susan Bates, Herb Kotz, Tito Fojo, Phase I Trial and Pharmacokinetic Study of BMS-247550, an Epothilone B Analog, Administered Intravenously on a Daily Schedule for Five Days Journal of Clinical Oncology. ,vol. 21, pp. 1866- 1873 ,(2003) , 10.1200/JCO.2003.03.063
M. Wartmann, K. Altmann, The biology and medicinal chemistry of epothilones. Current Medicinal Chemistry - Anti-cancer Agents. ,vol. 2, pp. 123- 148 ,(2012) , 10.2174/1568011023354489
Richard Simon, Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials. ,vol. 10, pp. 1- 10 ,(1989) , 10.1016/0197-2456(89)90015-9
Frances A. Shepherd, Janet Dancey, Rodryg Ramlau, Karin Mattson, Richard Gralla, Mark O’Rourke, Nathan Levitan, Laurent Gressot, Mark Vincent, Ronald Burkes, Susan Coughlin, Yong Kim, Jocelyne Berille, Prospective Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non–Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy Journal of Clinical Oncology. ,vol. 18, pp. 2095- 2103 ,(2000) , 10.1200/JCO.2000.18.10.2095
Jose R. Pereira, Filippo De Marinis, Joachim von Pawel, Ulrich Gatzemeier, Thomas Chang Yao Tsao, Miklos Pless, Thomas Muller, Hong-Liang Lim, Christopher Desch, Klara Szondy, Radj Gervais, Shaharyar, Christian Manegold, Sofia Paul, Paolo Paoletti, Lawrence Einhorn, Paul A. Bunn, Nasser Hanna, Frances A. Shepherd, Frank V. Fossella, Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients With Non–Small-Cell Lung Cancer Previously Treated With Chemotherapy Journal of Clinical Oncology. ,vol. 22, pp. 1589- 1597 ,(2004) , 10.1200/JCO.2004.08.163
Maha Hussain, Catherine M Tangen, Primo N Lara Jr, Ulka N Vaishampayan, Daniel P Petrylak, A Dimitrios Colevas, Wael A Sakr, E David Crawford, None, Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: A Southwest Oncology Group Trial S0111 Journal of Clinical Oncology. ,vol. 23, pp. 8724- 8729 ,(2005) , 10.1200/JCO.2005.02.4448