Phase I Clinical and Pharmacokinetic Study of BMS-247550, a Novel Derivative of Epothilone B, in Solid Tumors

Clinical Cancer Research

Volumn 10, Issue 4, 2004, Pages 1289-1298

  Mani, Sridhar ^a,c   McDaid, Hayley ^a,b   Hamilton, Anne ^d   Hochster, Howard ^d   Cohen, Marvin B ^e   Khabelle, Dineo ^a,c   Griffin, Tom ^e   Lebwohl, David E ^e   Liebes, Leonard ^d   Muggia, Franco ^d   Horwitz, Susan Band ^a,b,c  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^b Department of Molecular Pharmacology ^*  (United States)

^c ALBERT EINSTEIN CANCER CENTER   (United States)

^d NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; EPOTHILONE B; GEMCITABINE; IXABEPILONE; PACLITAXEL; TAXANE DERIVATIVE; TOPOTECAN;

ABDOMINAL DISCOMFORT; ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ARTICLE; BONE MARROW SUPPRESSION; BREAST CANCER; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONSTIPATION; CONTINUOUS INFUSION; DIARRHEA; DOSE LIMITING TOXICITY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG TOXICITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL DISEASE; GASTROINTESTINAL REFLUX; HUMAN; INTESTINE OBSTRUCTION; MALE; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; NAUSEA; NEUROLOGIC DISEASE; NEUROPATHY; NEUTROPENIA; OVARY CANCER; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SENSORY DYSFUNCTION; SOLID TUMOR; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; EPOTHILONES; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MODELS, CHEMICAL; NEOPLASMS; TIME FACTORS;

EID: 12144285977     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-0919-03     Document Type: Article

References (40)

1. Rowinsky, E. K. The development and clinical utlility of the taxane class of antimicrotubule chemotherapy agents. Annu. Rev. Med., 48: 353-374, 1997.
2. Gottesman, M. M., Pastan, I., and Ambudkar, S. V. P-glycoprotein and multidrug resistance. Curr. Opin. Genet. Dev., 6: 610-617, 1996.
3. He, L., Orr, G. A., and Horwitz, S. B. Novel molecules that interact with microtubules and have functional activity similar to Taxol. Drug Discov. Today, 6: 1153-1164, 2001.
4. Gerth, K., Steinmetz, H., Hofle, G., Irschik, H., and Reichenbach, H. Epoithilones A and B: antifungal and cytotoxic compounds from Sorangium cellulosum (Myxobacteria). Production, physiochemical and biological properties. J. Antibiot. (Tokyo), 49: 560-563, 1996.
5. Su, D-S., Meng, D., Bertinato, P., Bertinato, P., Danishefsky, S. J., Zheng, Y-H., Chou, T-C., He, L., and Horwitz, S. B. Total synthesis of (-)Epothilone B: an extension of the Suzuki coupling method and insights into structure-activity relationships of the epothilones. Angew. Chem. Int. Ed. Engl., 36: 757-759, 1997.
6. Balog, A., Meng, D., Kamenecka, T., Bertinato, P., Su, D-S., Sorensen, E. J., and Danishefsky, S. J. Total synthesis of (-) epothilone A. Angew. Chem., 35: 2801-2803, 1996.
7. Nicolaou, K. C., Winssinger, N., Pastor, J., Ninkovic, S., Sarabia, F., He, Y., Vourloumis, D., Yang, Z., Li, T., Giannakakou, P., and Hamel, E. Synthesis of epothilones A and B in solid and solution phase. Nature (Lond.), 387: 268-272, 1997.
8. Bollag, D. M., McQueneym, P. A., Zhu, J., Hensens, O., Koupal, L., Liesch, J., Goetz, M., Lazarides, E., and Woods, C. M. Epothilones, a new class of microtubule-stabilizing agents with a Taxol-like mechanism of action. Cancer Res., 55: 2325-2333, 1995.
9. Rubin, E. H., Siu, L. L., Beers, S., Moore, M. J., Thompson, C., Becker, T., et al. A Phase I clinical and pharmacologic trial of weekly epothilone B in patients with advanced malignancies. Proc. Am. Soc. Clin. Oncol., 20: 107a, 2001.
10. Lee, F. Y., Borzilleri, R., Fairchild, C. R., Kim, S. H., Long, B. H., Reventos-Suarez, C., Vite, G. D., Rose, W. C., and Kramer, R. A. BMS-247550: a novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin. Cancer Res., 7: 1429-1437, 2001.
11. Bristol-Myers Squibb. Investigator's Brochure. Wallingford, CT: Bristol-Myers Squibb, 2001.
12. Simon, R., Freidlin, B., Rubinstein, L., Arbuck, S. G., Collins, J., and Christian, M. C. Accelerated titration designs for Phase I clinical trials in oncology. J. Natl. Cancer Inst. (Bethesda), 89: 1138-1147, 1997.
13. Spriggs, D., Soignet, S., Bienvenu, B., Letrent, S., Lebwohl, D., Jones, S., and Burris H. Phase I first in-man study of the epothilone B analog BMS-247550 in patients with advanced cancer. Proc. Am. Soc. Clin. Oncol., 20: 108a, 2001.
14. Miller, A. B., Hoogstraten, B., Staquet, M., and Winkler, A. Reporting results of cancer treatment. Cancer (Phila.), 47: 207-214, 1981.
15. Arezzo, J. C. New developments in the diagnosis of diabetic neuropathy. Am. J. Med., 10: 9S-16S, 1999.
16. Dyck, P. J. Evaluative procedures to detect, characterize, and assess the severity of diabetic neuropathy. Diabet. Med. 8 Spec. No. S48-5, 1998.
17. Massy-Westropp, N. The effects of normal human variability and hand activity on sensory testing with the full Semmes-Weinstein monofilaments kit. J. Hand Ther., 15: 48-52, 2002.
18. Lipton, R. B., Galer, B. S., Dutcher, J. P., Portenoy, R. K., Pahmer, V., Meller, F., Arezzo, J. C., and Wiernik, P. H. Large and small fibre type sensory dysfunction in patients with cancer. J. Neurol. Neurosurg. Psychiatry, 54: 706-709, 1991.
19. Leffler, C. T., Gozani, S. N., and Cros, D. Median neuropathy at the wrist: diagnostic utility of clinical findings and an automated electrodiagnostic device. J. Occup. Environ. Med., 42: 398-409, 2000.
20. Kong, X., and Oiu, T. Latency change estimation for evoked potentials: a comparison of algorithms. Med. Biol. Eng. Comput., 39: 208-224, 2001.
21. Fisher, M. A., and Hoffen, B. F-wave analysis in patients with carpal tunnel syndrome. Electromyogr. Clin. Neurophysiol., 37: 27-31, 1997.
22. Cortes, J. E., and Pazdur, R. Docetaxel. J. Clin. Oncol., 13: 2643-2655, 1995.
23. Hidalgo, M., Aylesworth, C., Hammond, L. A., Britten, C. D., Weiss, G., Stephenson, J., Jr., Schwartz, G., Patnaik, A., Smith, L., Molpus, K., et al. Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. J. Clin. Oncol., 19: 2493-2503, 2001.
24. Tripathi, R., Gadgeel, S. M., Wozniak, A. J., and Ganapathi, R. Phase I clinical trial of BMS-247550 (epothilone B derivative) in adult patients with advanced solid tumors. Proc. Am. Soc. Clin. Oncol., 21: 102a, 2002.
25. Sonnichsen, D. S., and Relling, M. V. Clinical pharmacokinetics of paclitaxel. Clin. Pharmacokinet., 27: 256-269, 1994.
26. Clarke, S. J., and Rivory, L. P. Clinical pharmacokinetics of docetaxel. Clin. Pharmacokinet., 36: 99-141, 1999.
27. Gibaldi, M., and Perrier, D. (eds.). Pharmacokinetics, 2nd ed. New York: Marcel Dekker Inc., 1982.
28. Howard, L. A., Sellers, E. M., and Tyndale, R. F. The role of pharmacogenetically-variable cytochrome P450 enzymes. Pharmacogenomics, 3: 185-199, 2002.
29. Damle, B. D., Letrent, S., Duncan, G., and Spriggs, D. Pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-247550, an epothilone analog, in patients with advanced solid tumors. Proc. Am. Soc. Clin. Oncol., 20: 68a, 2001.
30. Bristol-Myers Squibb Pharmaceutical Research Institute. Investigator Brochure, Version 3. Wallingford, CT: Bristol-Myers Squibb, July 2001.
31. Mick, R. Phase I clinical trial design. In: R. L. Schilsky, G. A. Milano, and M. J. Ratain (eds.), Principles of Antineoplastic Drug Development and Pharmacology, pp. 30-32. New York: Marcel Dekker, Inc., 1996.
32. Berry, B. W., and Erlichman, C. Clinical pharmacology of anticancer drugs. In: R. L. Schilsky, G. A. Milano, and M. J. Ratain (eds.), Principles of Antineoplastic Drug Development and Pharmacology, pp. 99-102. New York: Marcel Dekker, Inc., 1996.
33. Levi, F., Metzger, G., Massari, C., and Milano, G. Oxaliplatin: pharmacokinetics and chronopharmacological aspects. Clin. Pharmacokinet., 38: 1-21, 2000.
34. Okuno, S. H., Geyer, S. M., Maples, W. J., and Peters, S. Phase II study of epothilone B analog (BMS-247550) in soft tissue sarcomas: an interim report. Proc. Am. Soc. Clin. Oncol., 21: 114a, 2002.
35. Ajani, J. A., Shah, M. A., Bokemeyer, C., Lenz, H-J., Burris, H., Van Cutsem, E., Usakewicz, J., O Peeters, A., Voi, M., Lebwohl, D., and Safran, H. Phase II study of the novel epothilone BMS-247550 in patients with metastatic gastric adeocarcinoma previously treated with a taxane. Proc. Am. Soc. Clin. Oncol., 21: 109a, 2002.
36. Delbado, C., Lara, P. N., Vansteenkiste, J., Bonomi, P., Rosso, R., Schiller, J., DeCillis, A., Fernande, A., Drumheller, A., van Leeuwen, B., O Peeters, A., Voi, M., Lebwohl, D., and LeChevalier, T. Phase II study of the novel epothilone BMS-247550 in patients with recurrent or metastatic non-small cell lung cancer (NSCLC) who have failed first-line platinum-based chemotherapy. Proc. Am. Soc. Clin. Oncol., 21: 110, 2002.
37. Green, M. R. Perspectives and opportunities: docetaxel in the current and future treatment of non-small cell lung cancer. Semin. Oncol., 29 (Suppl. 12): 17-21, 2002.
38. McDaid, H. M., Mani, S., Shen, H-J., Muggia, F., Sonnichsen, D., and Horwitz, S. B. Validation of the pharmacodynamics of BMS-247550, an analog of epothilone B, during a Phase I clinical study. Clin. Cancer Res., 8: 2035-2043, 2002.
39. Abraham, J., Agrawal, M., Bakke, S., Rutt, A., Edgerly, M., Balis, F. M., Widemann, B., Davis, L., Damle, B., Sonnichsen, D., 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., 21: 1866-1873, 2003.
40. Hao, D., Hammond, L. A., DeBono, J. S., Patnaik, A., Tocher, A. W., and Rowinsky, E. Continuous weekly administration of the epothilone-B derivative, BMS-247550 (NSC 10428): a Phase I and pharmacokinetic study. Proc. Am. Soc. Clin. Oncol., 21: 103a, 2002.