A phase I clinical trial of ixabepilone (BMS-247550), an epothilone B analog, administered intravenously on a daily schedule for 3 days

Cancer

Volumn 103, Issue 9, 2005, Pages 1932-1938

  Zhuang, Sen H ^a   Agrawal, Manish ^a   Edgerly, Maureen ^a   Bakke, Susan ^a   Kotz, Herb ^a   Thambi, Paul ^a   Rutt, Ann ^a   Balis, Frank M ^a   Bates, Susan ^a   Fojo, Tito ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

BMS 247550; Epothilones; Ixabepilone; Microtubules; Taxanes

Indexed keywords

ANTINEOPLASTIC AGENT; EPOTHILONE B; EPOTHILONE DERIVATIVE; IXABEPILONE;

ALOPECIA; ANOREXIA; ARTHRALGIA; ARTICLE; BREAST CARCINOMA; CANCER CHEMOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; COLON CARCINOMA; CONSTIPATION; DIARRHEA; DRUG DOSE REGIMEN; FATIGUE; FEMALE; HEAD AND NECK CANCER; HUMAN; HYPONATREMIA; ILEUS; KIDNEY CARCINOMA; LUNG CARCINOMA; MALE; MESOTHELIOMA; MICROTUBULE; MYALGIA; NAIL DISEASE; NEUTROPENIA; OVARY CARCINOMA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; DRUG ADMINISTRATION SCHEDULE; EPOTHILONES; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS;

EID: 20244376916     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/cncr.20977     Document Type: Article

References (23)

1. BoIIag DM, McQueney PA, Zhu J, et al. Epothilones, a new class of microtubule-stabilizing agents with a Taxol-like mechanism of action. Cancer Res. 1995;55:2325-2333.
2. 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). J Biol Chem. 1997;272:2534-2541.
3. Su D, Balog A, Men D. Structure-activity relationships of the epothilones and the first in vivo comparison with paclitaxel. Angew Chem Int Ed. 1997;36:2093-2096.
4. Nicolaou KC, Winssinger N, Pastor J, et al. Synthesis of epothilones A and B in solid and solution phase. Nature. 1997;387:268-272.
5. Lee FY, Borzilleri R, Fairchild CR, et al. BMS-247550: a novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin Cancer Res. 2001;7:1429-1437.
6. Muhlradt PF, Sasse F. Epothilone B stabilizes microtubuli of macrophages like Taxol without showing Taxol-like endotoxin activity. Cancer Res. 1997;57:3344-3346.
7. Gerth K, Bedorf N, Hofle G, et al. Epothilones A and B: antifungal and cytotoxic compounds from Sorangium cellulosum (Myxobacteria)-production, physico-chemical and biological properties. J Antibiot (Tokyo). 1996;49:560-563.
8. Johnson J, Kim SH, Bifano M, et al. Synthesis, structure proof, and biological activity of epothilone cyclopropanes. Org Lett. 2000;2:1537-1540.
9. Low JA, Wedam SB, Brufsky A, et al. A phase 2 trial of BMS-247550 (ixabepilone), an epothilone B analog, given daily × 5 in breast cancer [abstract]. Proc Am Soc Clin Oncol. 2004;22:5456.
10. Agrawal M, Edgerly M, Fojo T, Kotz H. Treatment of recurrent cervical adenocarcinoma with BMS-247550, an epothilone B analog. Gynecol Oncol. 2003;90:96-99.
11. Whitehead RP, McCoy SA, Rivkin SE, Gross HM, Conrad ME, Abbruzzese JL. A phase II trial of epothilone B analogue BMS-247550 (NSC #710428) in patients with advanced pancreas cancer: a Southwest Oncology Group Study [abstract]. Proc Am Soc Clin Oncol. 2004;22:4012.
12. Hussein M, Faulkner J, Vaishampayan U, et al. Epothilone B (Epo-B) analogue BMS-247550 (NSC #710428) administered every 21 days in patients (pts) with hormone refractory prostate cancer (HRPC). A Southwest Oncology Group Study (S0111) [abstract]. Proc Am Soc Clin Oncol. 2004;22:4510.
13. Kelly WK, Galsky MD, Small EJ, et al. Multi-institutional trial of the epothilone B analogue BMS-247550 with or without estramustine phosphate (EMP) in patients with progressive castrate-metastatic prostate cancer (PCMPC): updated results [abstract]. Proc Am Soc Clin Oncol. 2004;22:4509.
14. Smaletz O, Galsky M, Scher HI, et al. Pilot study of epothilone B analog (BMS-247550) and estramustine phosphate in patients with progressive metastatic prostate cancer following castration. Ann Oncol. 2003;14:1518-1524.
15. Zhuang SH, Menefee M, Kotz H, et al. A phase II clinical trial of BMS-247550 (ixabepilone), a microtubule-stabilizing agent in renal cell cancer [abstract]. Proc Am Soc Clin Oncol. 2004;22:4550.
16. Abraham J, Agrawal M, Bakke S, et al. Phase I trial and pharmacokinetic study of BMS-247550, an epothilone B analog, administered intravenously on a daily schedule for five days. J Clin Oncol. 2003;21:1866-1873.
17. Mani S, McDaid H, Hamilton A, et al. Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors. Clin Cancer Res. 2004;10:1289-1298.
18. Therasse P, Arbuck SG, Eisenhauer EA, 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;92:205-216.
19. Rowinsky EK. The taxanes: dosing and scheduling considerations. Oncology (Huntingt). 1997;11:7-19.
20. Zhan Z, Scala S, Monks A, et al. Resistance to paclitaxel mediated by P-glycoprotein can be modulated by changes in the schedule of administration. Cancer Chemother Pharmacol. 1997;40:245-250.
21. Gianni L. Theoretical and practical aspects of paclitaxel scheduling. Ann Oncol. 1995;6:861-863.
22. Eng C, Kindler HL, Nattam S, et al. A phase II trial of the epothilone B analog, BMS-247550, in patients with previously treated advanced colorectal cancer. Ann Oncol. 2004;15:928-932.
23. Nabholtz JM, Gelmon K, Bontenbal M, et al. Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J Clin Oncol. 1996;14:1858-1867.