Phase I and pharmacokinetic study of Genexol-PM, a Cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies

Clinical Cancer Research

Volumn 10, Issue 11, 2004, Pages 3708-3716

  Kim, Tae You ^a   Kim, Dong Wan ^a   Chung, Jae Yong ^a   Shin, Sang Goo ^a   Kim, Sung Chul ^b   Heo, Dae Seog ^a   Kim, Noe Kyeong ^a   Bang, Yung Jue ^a  

^a Seoul National University College of Medicine   (South Korea)

^b Samyang Research Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; CREMOPHOR; CYCLOPHOSPHAMIDE; DOCETAXEL; ETOPOSIDE; GEMCITABINE; GENEXOL PM; PACLITAXEL; PNU 166945; TAXANE DERIVATIVE; TOPOTECAN;

ADULT; ADVANCED CANCER; ALOPECIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COUGHING; DIARRHEA; DOSE LIMITING TOXICITY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG TOXICITY; DYSPNEA; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERSENSITIVITY; LIVER TOXICITY; MALE; MAXIMUM TOLERATED DOSE; MICELLE; MYALGIA; NAUSEA; NEPHROTOXICITY; NEUROMUSCULAR DISEASE; NEUROPATHY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; POLYNEUROPATHY; PRIORITY JOURNAL; PRURITUS; SENSORY NEUROPATHY; SKIN MANIFESTATION; SKIN TOXICITY; URTICARIA;

ADULT; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MICELLES; MIDDLE AGED; NEOPLASMS; PACLITAXEL; POLYETHYLENE GLYCOLS; POLYMERS; TIME FACTORS;

EID: 2542559832     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-03-0655     Document Type: Article

References (43)

1. Crown J, O'Leary M. The taxanes: an update. Lancet 2000;355:1176-8.
2. Rowinsky E, Donehower R. Paclitaxel. N Engl J Med 1995;332:1004-14.
3. Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer 2001;37:1590-8.
4. van Zuylen L, Karlsson MO, Verweij J, et al. Pharmacokinetic modeling of paclitaxel encapsulation in Cremophor EL micelles. Cancer Chemother Pharmacol 2001;47:309-18.
5. Sparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. Nonlinear pharmacokinetics of paclitaxel in mice results from the pharmaceutical vehicle Cremophor EL. Cancer Res 1996;56:2112-5.
6. Sparreboom A, van Zuylen L, Brouwer E, et al. Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications. Cancer Res 1999;59:1454-7.
7. Henningsson A, Karlsson MO, Vigano L, Gianni L, Verweij J, Sparreboom A. Mechanism-based pharmacokinetic model for paclitaxel. J Clin Oncol 2001;19:4065-73.
8. Waugh WN, Trissel LA, Stella VJ. Stability, compatibility, and plasticizer extraction of taxol (NSC-125973) injection diluted in infusion solutions and stored in various containers. Am J Hosp Pharm 1991;48:1520-4.
9. Liebmann J, Cook JA, Lipschultz C, Teague D, Fisher J, Mitchell JB. The influence of Cremophor EL on the cell cycle effects of paclitaxel (Taxol) in human tumor cell lines. Cancer Chemother Pharmacol 1994;33:331-9.
10. Schuurhuis GJ, Broxterman HJ, Pinedo HM, et al. The polyoxyethylene castor oil Cremophor EL modifies multidrug resistance. Br J Cancer 1990;62:591-4.
11. Woodcock DM, Jefferson S, Linsenmeyer ME, et al. Reversal of the multidrug resistance phenotype with cremophor EL, a common vehicle for water-insoluble vitamins and drugs. Cancer Res 1990;50:4199-203.
12. Webster L, Linsenmeyer M, Millward M, Morton C, Bishop J, Woodcock D. Measurement of cremophor EL following taxol: plasma levels sufficient to reverse drug exclusion mediated by the multidrug-resistant phenotype. J Natl Cancer Inst 1993;85:1685-90.
13. van Zuylen L, Verweij J, Sparreboom A. Role of formulation vehicles in taxane pharmacology. Investig New Drugs 2001;19:125-41.
14. Nuijen B, Bouma M, Schellens JH, Beijnen JH. Progress in the development of alternative pharmaceutical formulations of taxanes. Invest New Drugs 2001;19:143-53.
15. Lundberg BB, Risovic V, Ramaswamy M, Wasan KM. A lipophilic paclitaxel derivative incorporated in a lipid emulsion for parenteral administration. J Control Release 2003;86:93-100.
16. Mu L, Feng SS. A novel controlled release formulation for the anticancer drug paclitaxel (Taxol((R))): PLGA nanoparticles containing vitamin E TPGS. J Control Release 2003;86:33-48.
17. Fonseca C, Simoes S, Gaspar R. Paclitaxel-loaded PLGA nanoparticles: preparation, physicochemical characterization and in vitro antitumoral activity. J Control Release 2002;83:273-86.
18. Loos WJ, Szebeni J, ten Tije AJ, et al. Preclinical evaluation of alternative pharmaceutical delivery vehicles for paclitaxel. Anticancer Drugs 2002;13:767-75.
19. Sparreboom A, Wolff AC, Verweij J, et al. Disposition of docosahexaenoic acid-Paclitaxel, a novel taxane, in blood: in vitro and clinical pharmacokinetic studies. Clin Cancer Res 2003;9:151-9.
20. Ibrahim NK, Desai N, Legha S, et al. Phase I and pharmacokinetic study of ABI-007, a Cremophor-free, protein-stabilized, nanoparticle formulation of Pactitaxel. Clin Cancer Res 2002;8:1038-44.
21. Meerum Terwogt JM, ten Bokkel Huinink WW, Schellens JH, et al. Phase I clinical and pharmacokinetic study of PNU166945, a novel water-soluble polymer-conjugated prodrug of paclitaxel. Anticancer Drugs 2001;12:315-23.
22. Lavasanifar A, Samuel J, Kwon GS: Poly(ethylene oxide) -block-poly(L-amino acid) micelles for drug delivery Adv Drug Deliv Rev 2002;54:169-90.
23. Kwon GS, Okano T. Soluble self-assembled block copolymers for drug delivery. Pharm Res 1999;16:597-600.
24. Kataoka K, Matsumoto T, Yokoyama M, et al. Doxorubicin-loaded poly(ethylene glycol)-poly(beta-benzyl-L-aspartate) copolymer micelles: their pharmaceutical characteristics and biological significance. J Control Release 64:143-53, 2000.
25. Liggins RT, Burt HM. Polyether-polyester diblock copolymers for the preparation of paclitaxel loaded polymeric micelle formulations. Adv Drug Deliv Rev 2002;54:191-202.
26. Kim SC, Kim DW, Shim YH, et al. In vivo evaluation of polymeric micellar paclitaxel formulation: toxicity and efficacy. J Control Release 2001;72:191-202.
27. Gianni L, Kearns CM, Giani A, et al. Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 1995;13:180-90.
28. O'Dwyer PJ, King SA, Fortner CL, Leyland-Jones B. Hypersensitivity reactions to teniposide (VM-26): an analysis. J Clin Oncol 1986;4:1262-9.
29. Weiss RB, Donehower RC, Wiernik PH, et al. Hypersensitivity reactions from taxol. J Clin Oncol 1990;8:1263-8.
30. Rowinsky EK, Chaudhry V, Comblath DR, Donehower RC. Neurotoxicity of Taxol. J Natl Cancer Inst Monogr 1993;15:107-15.
31. Windebank AJ, Blexrud MD, de Groen PC. Potential neurotoxicity of the solvent vehicle for cyclosporine. J Pharmacol Exp Ther 1994;268:1051-6.
32. Gelderblom H, Mross K, ten Tije AJ, et al. Comparative pharmacokinetics of unbound paclitaxel during 1- and 3-hour infusions. J Clin Oncol 2002;20:574-81.
33. Mross K, Hollander N, Hauns B, Schumacher M, Maier-Lenz H. The pharmacokinetics of a 1-h paclitaxel infusion. Cancer Chemother Pharmacol 2000;45:463-70.
34. Cabanes A, Briggs KE, Gokhale PC, Treat JA, Rahman A. Comparative in vivo studies with paclitaxel and liposome-encapsulated paclitaxel. Int J Oncol 1998;2:1035-40.
35. Treat J, Damjanov N, Huang C, Zrada S, Rahman A. Liposomal-encapsulated chemotherapy: preliminary results of a phase I study of a novel liposomal paclitaxel. Oncology (Huntingt) Suppl 2001;7:44-8.
36. Schmitt-Sody M, Strieth S, Krasnici S, et al. Neovascular targeting therapy: paclitaxel encapsulated in cationic liposomes improves antitumoral efficacy. Clin Cancer Res 2003;9:2335-41.
37. Bradley MO, Webb NL, Anthony FH, et al. Tumor targeting by covalent conjugation of a natural fatty acid to paclitaxel. Clin Cancer Res 2001;10:3229-38.
38. Wolff AC, Donehower RC, Carducci MK, et al. Phase I study of docosahexaenoic acid-paclitaxel: a taxane-fatty acid conjugate with a unique pharmacology and toxicity profile. Clin Cancer Res 2003;9:3589-97.
39. Li C. Poly(L-glutamic acid)-anticancer drug conjugates. Adv Drug Deliv Rev 2002;54:695-713.
40. Todd R, Sludden J, Boddy AV, et al. Phase I and pharmacological study of CT-2103, a poly(L-glutamic cid)-paclitaxel conjugate, Proc Am Soc Clin Oncol 2001;20(Part 1):111a (439).
41. O'Shaughnessy J, Tjulandin S, Davidson N, et al. ABI-007 (ABRAXANE™), a nanoparticle albumin-bound (nab) paclitaxel demonstrates superior efficacy vs taxol in MBC: a phase III trial, Breast Cancer Res. Treat 2003;82(Suppl 1); 44.
42. Rowinsky EK. Taxane analogues: distinguishing royal robes from the "Emperor's New Clothes". Clin Cancer Res 2002;8:2759-63.
43. Maeda H, Wu J, Sawa T, Matsumura Y, Hori K. Tumor vascular permeability and the EPR effect in macromolecular therapeutics: a review. J Control Release 2000;65:271-84.