Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy

Breast Cancer Research and Treatment

Volumn 123, Issue 3, 2010, Pages 837-842

  Morrow, Phuong K ^a   Divers, Stephen ^b   Provencher, Louise ^c   Luoh, Shiuh Wen ^d   Petrella, Teresa M ^e   Giurescu, Marius ^f   Schmelter, Thomas ^f   Wang, Yao ^g   Hortobagyi, Gabriel N ^a   Vahdat, Linda T ^h  

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

^b Genesis Cancer Center   (United States)

^c UNIVERSITÉ LAVAL   (Canada)

^d OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^e SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^f BAYER PHARMA AG   (Germany)

^g BAYER CORPORATION   (United States)

^h WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

Breast cancer; Epothilones; Metastatic; Phase II; Sagopilone

Indexed keywords

ANTHRACYCLINE DERIVATIVE; CAPECITABINE; SAGOPILONE; TAXANE DERIVATIVE; TRASTUZUMAB; ANTINEOPLASTIC AGENT; BENZOTHIAZOLE DERIVATIVE; EPOTHILONE DERIVATIVE;

ADULT; AGED; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; BREAST METASTASIS; CANCER RADIOTHERAPY; CONSTIPATION; CONTINUOUS INFUSION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; LEG PAIN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; MYALGIA; NAUSEA; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SENSORY NEUROPATHY; TREATMENT OUTCOME; VOMITING; BREAST TUMOR; CANADA; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; DISEASE COURSE; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; GERMANY; INFUSION; KAPLAN MEIER METHOD; METASTASIS; MIDDLE AGED; NEUROLOGIC DISEASE; PROSPECTIVE STUDY; TIME; TREATMENT FAILURE; UNITED STATES;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZOTHIAZOLES; BREAST NEOPLASMS; CANADA; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; EPOTHILONES; FATIGUE; FEMALE; GERMANY; HUMANS; INFUSIONS, PARENTERAL; KAPLAN-MEIER ESTIMATE; MIDDLE AGED; NERVOUS SYSTEM DISEASES; PROSPECTIVE STUDIES; TIME FACTORS; TREATMENT FAILURE; UNITED STATES;

EID: 79952118633     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-010-1102-x     Document Type: Article

References (22)

1. Kamangar F, Dores GM, Anderson WF (2006) Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 24:2137-2150. doi: 10.1200/JCO.2005.05.2308 (Pubitemid 46655601)
2. Giordano SH, Buzdar AU, Smith TL, Kau S-W, Yang Y, Hortobagyi GN (2004) Is breast cancer survival improving? Cancer 100:44-52. doi:10.1002/cncr.11859 (Pubitemid 37553538)
3. Thomas ES, Gomez HL, Li RK, Chung H-C, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roché HH (2007) Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 25:5210-5217. doi:10.1200/JCO.2007.12.6557 (Pubitemid 350232252)
4. Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN (2007) Efficacy and safety of ixabepilone (BMS-247550) in a Phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol 25: 3407-3414. doi:10.1200/JCO.2006.09.3849 (Pubitemid 47310876)
5. Fornier MN (2007) Epothilones in breast cancer: review of clinical experience. Ann Oncol 18(Suppl 5):v16-v21. doi:10.1093/annonc/mdm174
6. Morris PG, Fornier MN (2009) Ixabepilone and other epothilones: microtubule-Targeting agents for metastatic breast cancer. Clin Adv Hematol Oncol 7:115-122
7. Egerton N (2008) Ixabepilone (ixempra), a therapeutic option for locally advanced or metastatic breast cancer. P T 33:523-531
8. Toppmeyer DL, Goodin S (2009) Ixabepilone, a new treatment option for metastatic breast cancer. Am J Clin Oncol (In press). doi:10.1097/COC. 0b013e3181b9cd52
9. Cheng KL, Bradley T, Budman DR (2008) Novel microtubuletargeting agents-The epothilones. Biologics 2:789-811
10. Hoffman J, Fichtner I, Klar U (2006) ZK-EPO, a potent third generation epothilone, is effective in models of breast cancer metastasis. Presented at AACR; abstract 511
11. Schmid P, Kiewe P, Possinger K, Korfel A, Lindemann S, Giurescu M, Reif S, Wiesinger H, Thiel E, Kühnhardt D (2010) Phase I study of the novel, fully synthetic epothilone sagopilone (ZK-EPO) in patients with solid tumors. Ann Oncol 21:633-639. doi:10.1093/annonc/mdp491
12. Vasey PA, Paul J, Birt A, Junor EJ, Reed NS, Symonds RPH, Atkinson R, Graham J, Crawford SM, Coleman R, Thomas H, Davis J, Eggleton SP, Kaye SB, for the Scottish Gynaecological Cancer Trials Group (1999) Docetaxel and cisplatin in combination as first-line chemotherapy for advanced epithelial ovarian cancer. J Clin Oncol 17:2069-2080 (Pubitemid 29318837)
13. National Cancer Institute (2010) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. http://ctep.cancer.gov/protocolDevelopment/electronic- Applications/docs/ctcaev3.pdf
14. Beer T, Smith DC, Hussain A, Alonso M, Neerukonda L, Hauke R, Wang Y, Giurescu M (2008) Phase II study of first-line sagopilone combined with prednisone in patients with metastatic androgen-independent prostate cancer (AIPC). Ann Oncol 19(Suppl 8):viii198, abstract 616P
15. Daud A, Weber J, Urbas P, Andrews S, Maker N, Sondak VK, DeConti RC (2009) Phase II trial of sagopilone (ZK-EPO), a novel synthetic epothilone, with significant activity in metastatic melanoma. J Clin Oncol (Meet Abstr) 27: Abstract 9031
16. McMeekin S, Patel R, Verschraegen C, Celano P, Burke J, Plaxe S, Ghatage P, Giurescu M, Stredder C, Wang Y (2008) Phase I/II study of sagopilone (ZK-EPO) plus carboplatin in women with recurrent platinum-sensitive ovarian cancer. Ann Oncol 19(Suppl 8):viii211, abstract 665O
17. Rubin EH, Rothermel J, Tesfaye F, Chen T, Hubert M, Ho Y-Y, Hsu C-H, Oza AM (2005) Phase I dose-finding study of weekly single-Agent patupilone in patients with advanced solid tumors. J Clin Oncol 23:9120-9129. doi:10.1200/JCO.2005.03.0981
18. Low JA, Wedam SB, Brufsky A, Berman A, Croarkin E, Parks R, Steinberg SM, Mannan N, Fojo T, Swain SM (2004) A phase 2 trial of BMS-247550 (ixabepilone), an epothilone B analog, given daily 9 5 in breast cancer. J Clin Oncol 22: Abstract 545
19. Thomas E, Tabernero J, Fornier M, Conte P, Fumoleau P, Lluch A, Vahdat LT, Bunnell CA, Burris HA, Viens P, Baselga J, Rivera E, Guarneri V, Poulart V, Klimovsky J, Lebwohl D, Martin M (2007) Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in patients with taxane-resistant metastatic breast cancer. J Clin Oncol 25:3399-3406. doi:10.1200/JCO. 2006.08.9102 (Pubitemid 47310875)
20. Bianchi G, Vitali G, Caraceni A, Ravaglia S, Capri G, Cundari S, Zanna C, Gianni L (2005) Symptomatic and neurophysiological responses of paclitaxel-or cisplatin-induced neuropathy to oral acetyl-L-carnitine. Eur J Cancer 41:1746-1750. doi:10.1016/j.ejca.2005.04.028 (Pubitemid 41132636)
21. Wang MS, Davis AA, Culver DG, Wang Q, Powers JC, Glass JD (2004) Calpain inhibition protects against Taxol-induced sensory neuropathy. Brain 127:671-679. doi:10.1093/brain/awh078 (Pubitemid 38295480)
22. Stubblefield MD, Vahdat LT, Balmaceda CM, Troxel AB, Hesdorffer CS, Gooch CL (2005) Glutamine as a neuroprotective agent in high-dose paclitaxel-induced peripheral neuropathy: A clinical and electrophysiologic study. Clin Oncol (R Coll Radiol) 17:271-276 (Pubitemid 40716452)