Effects of patupilone on the pharmacokinetics and pharmacodynamics of warfarin in patients with advanced malignancies: A Phase I Clinical Trial

Molecular Cancer Therapeutics

Volumn 10, Issue 1, 2011, Pages 209-217

  Tsimberidou, Apostolia Maria ^a   Takimoto, Chris H M ^a   Moulder, Stacy ^a   Uehara, Cynthia ^a   Mita, Monica ^a   Mita, Alain ^a   Urban, Patrick ^b   Tan, Eugene ^b   Wang, Yanfeng ^b   Vining, David ^c   Kurzrock, Razelle ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b CTRC Institute for Drug Development   (United States)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2C9; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPOTHILONE B; ESTROGEN RECEPTOR; PROGESTERONE RECEPTOR; WARFARIN;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BREAST CANCER; CLINICAL ARTICLE; COMBINATION CHEMOTHERAPY; DEHYDRATION; DIARRHEA; DRUG EFFECT; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; FATIGUE; FEMALE; HUMAN; INTERNATIONAL NORMALIZED RATIO; MALAISE; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PLASMA CLEARANCE; PRIORITY JOURNAL; SIDE EFFECT; SINGLE DRUG DOSE; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; EPOTHILONES; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; WARFARIN; YOUNG ADULT;

EID: 78751521502     PISSN: 15357163     EISSN: 15388514     Source Type: Journal    
DOI: 10.1158/1535-7163.MCT-10-0774     Document Type: Article

References (18)

1. Bollag DM, McQueney PA, Zhu J, Hensens O, Koupal L, Liesch J, et al. Epothilones, a new class of microtubule-stabilizing agents with a taxol-like mechanism of action. Cancer Res 1995;55:2325-33.
2. Wilson L, Jordan MA. Microtubule dynamics: taking aim at a moving target. Chem Biol 1995;2:569-73.
3. Altmann KH, Wartmann M, O'Reilly T. Epothilones and related structures-a new class of microtubule inhibitors with potent in vivo antitumor activity. Biochim Biophys Acta 2000;1470:M79-91.
4. Kowalski RJ, Giannakakou P, Hamel E. Activities of the microtubule-stabilizing agents epothilones A and B with purified tubulin and in cells resistant to paclitaxel (Taxol(R)). J Biol Chem 1997;272: 2534-41.
5. O'Reilly T, Wartmann M, Brueggen J, Allegrini PR, Floersheimer A, Maira M, et al. Pharmacokinetic profile of the microtubule stabilizer patupilone in tumor-bearing rodents and comparison of anti-cancer activity with other MTS in vitro and in vivo.Cancer Chemother Pharmacol 2008;62:1045-54.
6. Abrey LE, Wen P, Govindan R, Reimers HG, Rigas JR, Robins HI, et al. Patupilone for the treatment of recurrent/progressive brain metastases in patients (pts) with non-small cell lung cancer (NSCLC): An open-label phase II study [abstract 2033]. J Clin Oncol 2008;26:15s.
7. Beardsley EK, Saad F, Eigl B, Venner S, Hotte E, Winquist Y, et al. A phase II study of patupilone in patients (pts) with metastatic castration-resistant prostate cancer (CRPC) who have progressed after docetaxel [abstract 5139]. J Clin Oncol 2009;27:15s.
8. Casado E, Tabernero J, Melichar B, Bridgewater J, Bennouna J, Delord J, et al. Patupilone in chemotherapy-pretreated patients with advanced colorectal cancer (CRC) receiving nutritional support and intensive diarrhea management: A phase I multicenter trial [abstract 3593]. J Clin Oncol 2006;24:18s.
9. Forster M, Kaye S, Oza A, Sklenar I, Johri A, Cheung W, et al. A phase Ib and pharmacokinetic trial of patupilone combined with carboplatin in patients with advanced cancer. Clin Cancer Res 2007;13:4178-84.
10. Ten BokkelHuinink WW, Sufliarsky J, Smit WM, Spanik S, Wagnerova M, Hirte HW, et al. Safety and efficacy of patupilone in patients with advanced ovarian, primary fallopian, or primary peritoneal cancer: a phase I, open-label, dose-escalation study. J Clin Oncol 2009; 27:3097-103.
11. Zatloukal P, Mellemgaard A, Sanchez JM. Perry MC, Hamm JT. Activity of patupilone in advanced or metastatic non-small cell lung cancer (NSCLC): A phase II study. Ann Oncol 2008;19(Suppl 8):296P.
12. Vemulapalli S, Chintala L, Tsimberidou AM, Dhillon N, Lei X, Hong, D, et al. Clinical outcomes and factors predicting development of venous thromboembolic complications in patients with advanced refractory cancer in a Phase I Clinic: the M. D. Anderson Cancer Center experience. Am J Hematol 2009;84:408-13.
13. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008;133(Suppl):454S-545S.
14. Breckenridge A, Orme M, Wesseling H, Lewis RJ, Gibbons R. Pharmacokinetics and pharmacodynamics of the enantiomers of warfarin in man. Clinical Pharmacol Ther 1974;15:424-30.
15. Kaminsky LS, Zhang ZY. Human P450 metabolism of warfarin. Pharmac Ther 1997;73:67-74.
16. Benet L. FDA advisory committee for pharmaceutical science. Rockville, MD:FDA; 2004.
17. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-16.
18. Camidge R, Reigner B, Cassidy J, Grange S, Abt M, Weidekamm E, et al. Significant effect of capecitabine on the pharmacokinetics and pharmacodynamics of warfarin in patients with cancer. J Clin Oncol 2005;23:4719-25.