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Drug Evaluation

Ixabepilone for the treatment of solid tumors: a review of clinical data

, MD & , MD
Pages 423-435 | Published online: 06 Mar 2008

Bibliography

  • Westermann S, Weber K. Post-translational modifications regulate microtubule function. Nat Rev Mol Cell Biol 2003;4(12):938-47
  • Bollag 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(11):2325-33
  • Gerth K, Bedorf N, Hofle G, et al. Epothilons A and B: antifungal and cytotoxic compounds from Sorangium cellulosum (Myxobacteria). Production, physico-chemical and biological properties. J Antibiot (Tokyo) 1996;49(6):560-3
  • 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(4):2534-41
  • Goodin S, Kane MP, Rubin EH. Epothilones: mechanism of action and biologic activity. J Clin Oncol 2004;22(10):2015-25
  • Nettles JH, Li H, Cornett B, et al. The binding mode of epothilone A on alpha,beta-tubulin by electron crystallography. Science 2004;305(5685):866-9
  • 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(5):1429-37
  • Mani S, Macapinlac M Jr, Goel S, et al. The clinical development of new mitotic inhibitors that stabilize the microtubule. Anticancer Drugs 2004;15(6):553-8
  • Larkin JM, Kaye SB. Epothilones in the treatment of cancer. Expert Opin Investig Drugs 2006;15(6):691-702
  • Cortes J, Baselga J. Targeting the microtubules in breast cancer beyond taxanes: the epothilones. Oncologist 2007;12(3):271-80
  • Lee FY, Castaneda S, Inigo I, et al. Ixabepilone (BMS-247550) plus trastuzumab combination chemotherapy induces synergistic antitumor efficacy in HER2 dependent breast cancers and is accompanied by modulation of molecular response markers. J Clin Oncol (Meeting Abstracts) 2005;23(16 Suppl):561
  • 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(4):1289-98
  • 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(3):205-16
  • National Cancer Institute: Common Toxicity Criteria v 2.0 (April 30, 1999), In: Cancer Therapy Evaluation Program. Bethesda, MD: National Cancer Institute; 1999
  • Aghajanian C, Burris HA III, Jones S, et al. Phase I study of the novel epothilone analog ixabepilone (BMS-2t47550) in patients with advanced solid tumors and lymphomas. J Clin Oncol 2007;25(9):1082-8
  • Gadgeel SM, Wozniak A, Boinpally RR, et al. Phase I clinical trial of BMS-247550, a derivative of epothilone B, using accelerated titration 2B design. Clin Cancer Res 2005;11(17):6233-9
  • 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(9):1866-73
  • Zhuang SH, Agrawal M, Edgerly M, et al. A Phase I clinical trial of ixabepilone (BMS-247550), an epothilone B analog, administered intravenously on a daily schedule for 3 days. Cancer 2005;103(9):1932-8
  • Dickson N, Peck R, Wu C, et al. Ixabepilone given weekly in patients with advanced malignancies: final efficacy and safety results of a Phase I trial. J Clin Oncol (Meeting Abstracts) 2006;24(18 Suppl):2040
  • Anderson S, Dizon D, Sabbatini P, et al. Phase I trial of BMS-247550 and gemcitabine in patients with advanced solid tumor malignancies. J Clin Oncol (Meeting Abstracts) 2004;22(14 Suppl):2098
  • Plummer R, Molife R, Verrill M, et al. Phase I and pharmacokinetic study of BMS-247550 in combination with carboplatin in patients with advanced solid malignancies. J Clin Oncol (Meeting Abstracts) 2002;21:2125
  • Vahdat LT, Klimovsky J, Bunnell CA. Phase I/II trial in patients with metastatic breast cancer (MBC) previously treated with a taxane and an anthracycline: final safety data. J Clin Oncol (Meeting Abstracts) 2006;24(18 Suppl):10528
  • Goel S, Goldberg G, Iacono LC, et al. Effect of ketoconazole on the pharmacokinetics and pharmacodynamics of ixabepilone. J Clin Oncol (Meeting Abstracts) 2006;24(18 Suppl):2005
  • Takimoto CH, Liu PY, Lenz H, et al. A Phase I pharmacokinetic (PK) study of the Epothilone B analogue, ixabepilone (BMS-247550) in patients (pts) with advanced malignancies and varying degrees of hepatic impairment. A SWOG Early Therapeutics Committee and NCI Organ Dysfunction Working Group Trial. J Clin Oncol (Meeting Abstracts) 2006;24(18 Suppl):2004
  • Chuang E, Vahdat L, Caputo T, et al. Phase I clinical trial of ixabepilone and pegylated liposomal doxorubicin in patients with advanced breast or ovarian cancers: New York Cancer Consortium Trial P7229. J Clin Oncol (Meeting Abstracts) 2007;25(18 Suppl):2570
  • Shimizu T, Yamamoto N, Yamada Y, et al. Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors. Cancer Chemother Pharmacol 2007
  • Burris HA, Awada A, Jones S, et al. Phase I study of the novel epothilone BMS-247550 administered weekly in patients (pts) with advanced malignancies. J Clin Oncol (Meeting Abstracts) 2002;21:412
  • Sessa C, Perotti A, Llado A, et al. Phase I clinical study of the novel epothilone B analogue BMS-310705 given on a weekly schedule. Ann Oncol 2007;18(9):1548-53
  • McDaid HM, Mani S, Shen HJ, et al. Validation of the pharmacodynamics of BMS-247550, an analogue of epothilone B, during a Phase I clinical study. Clin Cancer Res 2002;8(7):2035-43
  • Denduluri N, Low JA, Lee JJ, et al. Phase II trial of ixabepilone, an epothilone B analog, in patients with metastatic breast cancer previously untreated with taxanes. J Clin Oncol 2007;25(23):3421-7
  • Low JA, Wedam SB, Lee JJ, et al. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in metastatic and locally advanced breast cancer. J Clin Oncol 2005;23(12):2726-34
  • Thomas E, Tabernero J, Fornier M, et al. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in patients with taxane-resistant metastatic breast cancer. J Clin Oncol 2007;25(23):3399-406
  • Perez EA, Lerzo G, Pivot X, et al. 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 2007;25(23):3407-14
  • Roche H, Yelle L, Cognetti F, et al. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, as first-line therapy in patients with metastatic breast cancer previously treated with anthracycline chemotherapy. J Clin Oncol 2007;25(23):3415-20
  • Rosenberg JE, Weinberg VK, Kelly WK, et al. Activity of second-line chemotherapy in docetaxel-refractory hormone-refractory prostate cancer patients: randomized Phase 2 study of ixabepilone or mitoxantrone and prednisone. Cancer 2007;110(3):556-63
  • Hussain M, Tangen CM, Lara PN Jr, et al. Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: a Southwest Oncology Group trial S0111. J Clin Oncol 2005;23(34):8724-9
  • Galsky MD, Small EJ, Oh WK, et al. Multi-institutional randomized Phase II trial of the epothilone B analog ixabepilone (BMS-247550) with or without estramustine phosphate in patients with progressive castrate metastatic prostate cancer. J Clin Oncol 2005;23(7):1439-46
  • Vansteenkiste J, Lara PN Jr, Le Chevalier T, et al. 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. J Clin Oncol 2007;25(23):3448-55
  • Fojo AT, Menefee ME, Poruchynsky M, et al. A translational study of ixabepilone (BMS-247550) in renal cell cancer (RCC): assessment of its activity and demonstration of target engagement in tumor cells. J Clin Oncol (Meeting Abstracts) 2005;23(16 Suppl):4541
  • Burtness B, Goldwasser MA, Axelrod R, et al. A randomized Phase II study of BMS-247550 (ixabepilone) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck. J Clin Oncol (Meeting Abstracts) 2006;24(18 Suppl):5532
  • Smith SM, Pro B, van Besien K, et al. A Phase II study of Epothilone B analog BMS-247550 (NSC 710428) in patients with relapsed aggressive non-Hodgkin's lymphomas. J Clin Oncol (Meeting Abstracts) 2005;23(16 Suppl):6625
  • O'Connor O, Straus D, Moskowitz C, et al. Targeting the microtubule apparatus in indolent and mantle cell lymphoma with the novel epothilone anlog BMS 247550 induces major and durable remissions in very drug resistant disease. J Clin Oncol (Meeting Abstracts) 2005;23(16 Suppl):6569
  • Thomas ES, Gomez HL, Li RK, et al. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 2007;25(33):5210-7
  • Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355(26):2733-43
  • Miller K, Wang M, Gralow J, et al. A randomized Phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer: a trial coordinated by the Eastern Cooperative Oncology Group (E2100). In: San Antonio Breast Cancer Symposium, San Antonio; 2005
  • Nabholtz JM, Gligorov J. The role of taxanes in the treatment of breast cancer. Expert Opin Pharmacother 2005;6(7):1073-94
  • Miller KD, McCaskill-Stevens W, Sisk J, et al. Combination versus sequential doxorubicin and docetaxel as primary chemotherapy for breast cancer: a randomized pilot trial of the Hoosier Oncology Group. J Clin Oncol 1999;17(10):3033-7
  • Sledge GW, Neuberg D, Bernardo P, et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 2003;21(4):588-92
  • Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351(15):1513-20
  • Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351(15):1502-12
  • Ratain MJ, Eisen T, Stadler WM, et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 2006;24(16):2505-12
  • Yang JC, Haworth L, Sherry RM, et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med 2003;349(5):427-34
  • Lee JJ, Low JA, Croarkin E, et al. Changes in neurologic function tests may predict neurotoxicity caused by ixabepilone. J Clin Oncol 2006;24(13):2084-91
  • Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol 2006;24(10):1633-42
  • Mielke S, Sparreboom A, Steinberg SM, et al. Association of Paclitaxel pharmacokinetics with the development of peripheral neuropathy in patients with advanced cancer. Clin Cancer Res 2005;11(13):4843-50
  • Sissung TM, Mross K, Steinberg SM, et al. Association of ABCB1 genotypes with paclitaxel-mediated peripheral neuropathy and neutropenia. Eur J Cancer 2006;42(17):2893-6
  • Mani S, McDaid HM, Grossman A, et al. Peripheral blood mononuclear and tumor cell pharmacodynamics of the novel epothilone B analogue, ixabepilone. Ann Oncol 2007;18(1):190-5
  • Lee H, Xu L, Wu S, et al. Predictive biomarker discovery and validation for the targeted chemotherapeutic ixabepilone. J Clin Oncol (Meeting Abstracts) 2006;24(18 Suppl):3011
  • Wu S, Chasalow S, Lee H, et al. Identification of predictive markers to differentiate ixabepilone from paclitaxel activity in ER-negative breast cancer patients. J Clin Oncol (Meeting Abstracts) 2007;25(18 Suppl):2525
  • Denduluri N, Lee JJ, Walshe J, et al. Phase II trial of ixabepilone, an epothilone B analog, given daily for three days every three weeks, in metastatic breast cancer. Invest New Drugs 2007;25(1):63-7
  • Posadas EM, Undevia S, Manchen E, et al. A Phase II study of Ixabepilone (BMS-247550) in metastatic renal-cell carcinoma. Cancer Biol Ther 2007;6(4)490-3
  • Okuno S, Maples WJ, Mahoney MR, et al. Evaluation of epothilone B analog in advanced soft tissue sarcoma: a Phase II study of the Phase II consortium. J Clin Oncol 2005;23(13):3069-73
  • Ajani JA, Safran H, Bokemeyer C, et al. A multi-center Phase II study of BMS-247550 (Ixabepilone) by two schedules in patients with metastatic gastric adenocarcinoma previously treated with a taxane. Invest New Drugs 24(5):441-6
  • Whitehead RP, McCoy S, Rivkin SE, et al. A Phase II trial of epothilone B analogue BMS-247550 (NSC #710428) ixabepilone, in patients with advanced pancreas cancer: a Southwest Oncology Group study. Invest New Drugs 2006;24(6):515-20
  • 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(6):928-32
  • Dreicer R, Li S, Manola J, et al. Phase 2 trial of epothilone B analog BMS-247550 (ixabepilone) in advanced carcinoma of the urothelium (E3800): a trial of the Eastern Cooperative Oncology Group. Cancer 2007;110(4):759-63
  • Singh DA, Kindler C, Eng L, et al. Phase II trial of the epothilone B analog BMS-247550 in patients with hepatobiliary cancer. J Clin Oncol (Meeting Abstracts) 2003;22:1127
  • Feldman DR, Kondagunta GV, Ginsberg MS, et al. Phase II Trial of ixabepilone in patients with cisplatin-refractory germ cell tumors. Invest New Drugs 2007;25(5):487-90
  • Pavlick AC, Millward M, Farrell K, et al. A Phase II study of epothilone B analog (EpoB)-BMS 247550 (NSC#710428) in stage IV malignant melanoma (MM). J Clin Oncol (Meeting Abstracts) 2004;22(14 Suppl):7542

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