Population pharmacokinetics of pegylated liposomal CKD-602 (S-CKD602) in patients with advanced malignancies

Journal of Clinical Pharmacology

Volumn 52, Issue 2, 2012, Pages 180-194

  Wu, Huali ^a   Ramanathan, Ramesh K ^b,d   Zamboni, Beth A ^f   Strychor, Sandra ^b,d   Ramalingam, Suresh ^b,d   Edwards, Robert P ^e   Friedland, David M ^b,d   Stoller, Ronald G ^b,d   Belani, Chandra P ^b,d   Maruca, Lauren J ^b,d   Bang, Yung Jue ^g,h   Zamboni, William C ^a,b,c  

^a UNC Hamner Institute for Drug Safety Sciences   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

^c Carolina Center for Cancer Nanotechology Excellence   (United States)

^d UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^e UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^f CARLOW UNIVERSITY   (United States)

^g Chong Kun Dang Research Institute   (South Korea)

^h Seoul National University Hospital   (South Korea)

Author keywords

liver metastasis; nonlinear kinetics; pegylated liposome; population pharmacokinetics; S CKD602

Indexed keywords

1,2 DISTEAROYL SN GLYCERO PHOSPHOCHOLINE; BELOTECAN; LIPOSOME; MACROGOL; N (CARBONYL METHOXYPOLYETHYLENE GLYCOL 2000) 1,2 DISTEAROYL SN GLYCERO PHOSPHOETHANOLAMINE; UNCLASSIFIED DRUG; CAMPTOTHECIN; DNA TOPOISOMERASE INHIBITOR; MACROGOL DERIVATIVE;

ADULT; ADVANCED CANCER; AGE; AGED; ARTICLE; CLINICAL ARTICLE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG RELEASE; ENCAPSULATION; FEMALE; HUMAN; LIVER TUMOR; MALE; SOLID TUMOR; ANALOGS AND DERIVATIVES; BIOLOGICAL MODEL; CHEMISTRY; CLINICAL TRIAL; METABOLISM; MIDDLE AGED; NEOPLASMS; PHASE 1 CLINICAL TRIAL;

ADULT; AGED; CAMPTOTHECIN; FEMALE; HUMANS; LIPOSOMES; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NEOPLASMS; POLYETHYLENE GLYCOLS; TOPOISOMERASE I INHIBITORS;

EID: 84863071445     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010394851     Document Type: Article

References (40)

1. Zamboni WC, Friedland DM, Ramalingam S, et al. Relationship between the plasma and tumor disposition of STEALTH liposomal CKD-602 and macrophages/dendritic cells (MDC) in mice bearing human tumor xenografts. Paper presented at: the American Association for Cancer Research ; 2006 Washington, DC ; 2006..
2. Zamboni WC, Strychor S, Joseph E, et al. Plasma and tumor disposition of STEALTH Liposomal CKD-602 (S-CKD602) and non-liposomal CKD-602, a camptothecin analogue, in mice bearing A375 human melanoma xenograft. Paper presented at: the American Association for Cancer Research ; ;..
3. Zamboni WC. Liposomal, nanoparticle, and conjugated formulations of anticancer agents. Clin Cancer Res. 2005 ; 11: 8230-8234 (Pubitemid 41746931)
4. Crul M. CKD-602. Chong Kun Dang. Curr Opin Investig Drugs. 2003 ; 4: 1455-1459
5. Lee JH, Lee JM, Lim KH, et al. Preclinical and phase 1 clinical studies with Ckd-602, a novel camptothecin derivative. Ann N Y Acad Sci. 2000 ; 922: 324-325 (Pubitemid 32050270)
6. Yu NY, Conway C, Pena RL, Chen JY. STEALTH liposomal CKD-602, a topoisomerase I inhibitor, improves the therapeutic index in human tumor xenograft models. Anticancer Res. 2007 ; 27 (4B). 2541-2545 (Pubitemid 47228101)
7. Lee DH, Kim SW, Suh C, et al. Belotecan, new camptothecin analogue, is active in patients with small-cell lung cancer: results of a multicenter early phase 2 study. Ann Oncol. 2008 ; 19: 123-127
8. Papahadjopoulos D, Allen TM, Gabizon A, et al. Sterically stabilized liposomes: improvements in pharmacokinetics and antitumor therapeutic efficacy. Proc Natl Acad Sci U S A. 1991 ; 88: 11460-11464 (Pubitemid 21916061)
9. 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: 271-284 (Pubitemid 30122932)
10. Markman M, Gordon AN, McGuire WP, Muggia FM. Liposomal anthracycline treatment for ovarian cancer. Semin Oncol. 2004 ; 31 (6 suppl 13). 91-105 (Pubitemid 40023243)
11. Krown SE, Northfelt DW, Osoba D, Stewart JS. Use of liposomal anthracyclines in Kaposi's sarcoma. Semin Oncol. 2004 ; 31 (6 suppl 13). 36-52 (Pubitemid 40023241)
12. Zamboni WC. Concept and clinical evaluation of carrier-mediated anticancer agents. Oncologist. 2008 ; 13: 248-260 (Pubitemid 351679900)
13. Innocenti F, Kroetz DL, Schuetz E, et al. Comprehensive pharmacogenetic analysis of irinotecan neutropenia and pharmacokinetics. J Clin Oncol. 2009 ; 27: 2604-2614
14. Slatter JG, Schaaf LJ, Sams JP, et al. Pharmacokinetics, metabolism, and excretion of irinotecan (CPT-11) following I.V. infusion of [(14)C]CPT-11 in cancer patients. Drug Metab Dispos. 2000 ; 28: 423-433 (Pubitemid 30185681)
15. Zamboni WC, Stewart CF, Thompson J, et al. Relationship between topotecan systemic exposure and tumor response in human neuroblastoma xenografts. J Natl Cancer Inst. 1998 ; 90: 505-511 (Pubitemid 28182543)
16. Stewart CF, Zamboni WC, Crom WR, et al. Topoisomerase I interactive drugs in children with cancer. Invest New Drugs. 1996 ; 14: 37-47 (Pubitemid 26283499)
17. Zamboni WC, Strychor S, Joseph E, et al. Plasma, tumor, and tissue disposition of STEALTH liposomal CKD-602 (S-CKD602) and nonliposomal CKD-602 in mice bearing A375 human melanoma xenografts. Clin Cancer Res. 2007 ; 13: 7217-7223 (Pubitemid 350276909)
18. Zamboni WC, Gajjar AJ, Mandrell TD, et al. A four-hour topotecan infusion achieves cytotoxic exposure throughout the neuraxis in the nonhuman primate model: implications for treatment of children with metastatic medulloblastoma. Clin Cancer Res. 1998 ; 4: 2537-2544 (Pubitemid 28477922)
19. Allen TM, Hansen C. Pharmacokinetics of stealth versus conventional liposomes: effect of dose. Biochim Biophys Acta. 1991 ; 1068: 133-141
20. Zamboni WC, Maruca LJ, Strychor S, et al. Bidirectional pharmacodynamic interaction between pegylated liposomal CKD-602 (S-CKD602) and monocytes in patients with refractory solid tumors [published online ahead of print July 14, 2010]. J Liposome Res.:
21. Zamboni WC. Liposomal, nanoparticle, and conjugated formulations of anticancer agents. Clin Cancer Res. 2005 ; 11: 8230-8234 (Pubitemid 41746931)
22. Zamboni WC, Maruca LJ, Strychor S, et al. Age and body composition related-effects on the pharmacokinetic disposition of STEALH liposomal CKD-602 (S-CKD602) in patients with advanced solid tumors. Paper presented at: American Society of Clinical Oncology, June 1-5, 2007; Chicago, IL. ; ;..
23. Sidone BJ, Edwards RP, Zamboni BA, Strychor S, Maruca LJ, Zamboni WC. Evaluation of body surface area (BSA) based dosing, age, and body composition as factors affecting the pharmacokinetic (PK) variability of STEALTH liposomal doxorubicin (Doxil). Paper presented at: American Association for Cancer Research, National Cancer Institute, European Organization for Research and Treatment of Cancer ; San Francisco, CA ;..
24. Zamboni WC, Strychor S, Maruca L, et al. Pharmacokinetic Study of pegylated liposomal CKD-602 (S-CKD602) in patients with advanced malignancies [published online ahead of print August 12, 2009]. Clin Pharmacol Ther. 2009 ; 86: 519-526
25. De Martinis M, Modesti M, Ginaldi L. Phenotypic and functional changes of circulating monocytes and polymorphonuclear leucocytes from elderly persons. Immunol Cell Biol. 2004 ; 82: 415-420 (Pubitemid 39141765)
26. Zamboni WC, Strychor S, Maruca L, et al. Pharmacokinetic study of pegylated liposomal CKD-602 (S-CKD602) in patients with advanced malignancies. Clin Pharmacol Ther. 2009 ; 86: 519-526
27. Zamboni WC, Ramalingam S, Friedland DM, et al. Phase 1 and pharmacokinetic study of pegylated liposomal CKD-602 in patients with advanced malignancies. Clin Cancer Res. 2009 ; 15: 1466-1472
28. Jones SF, Zamboni WC, Burris HA, et al. Phase 1 and pharmacokinetic (PK) study of IHL-305 (pegylated liposomal irinotecan) in patients with advanced solid tumors. Paper presented at: ASCO ; Orlando, FL ;..
29. Roy V, LaPlant BR, Gross GG, Bane CL, Palmieri FM. Phase 2 trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab- paclitaxel) (Abraxane) in combination with gemcitabine in patients with metastatic breast cancer (N0531). Ann Oncol. 2009 ; 20: 449-453
30. Giles FJ, Tallman MS, Garcia-Manero G, et al. Phase 1 and pharmacokinetic study of a low-clearance, unilamellar liposomal formulation of lurtotecan, a topoisomerase 1 inhibitor, in patients with advanced leukemia. Cancer. 2004 ; 100: 1449-1458 (Pubitemid 38366848)
31. Gelmon K, Hirte H, Fisher B, et al. A phase 1 study of OSI-211 given as an intravenous infusion days 1, 2, and 3 every three weeks in patients with solid cancers. Invest New Drugs. 2004 ; 22: 263-275 (Pubitemid 39012565)
32. Allen TM, Cullis PR. Drug delivery systems: entering the mainstream. Science. 2004 ; 303: 1818-1822 (Pubitemid 38374867)
33. Gabizon A, Isacson R, Rosengarten O, Tzemach D, Shmeeda H, Sapir R. An open-label study to evaluate dose and cycle dependence of the pharmacokinetics of pegylated liposomal doxorubicin. Cancer Chemother Pharmacol. 2008 ; 61: 695-702
34. Gabizon A, Shmeeda H, Barenholz Y. Pharmacokinetics of pegylated liposomal doxorubicin: review of animal and human studies. Clin Pharmacokinet. 2003 ; 42: 419-436 (Pubitemid 36649037)
35. Gabizon A, Tzemach D, Mak L, Bronstein M, Horowitz AT. Dose dependency of pharmacokinetics and therapeutic efficacy of pegylated liposomal doxorubicin (DOXIL) in murine models. J Drug Target. 2002 ; 10: 539-548 (Pubitemid 36124352)
36. Robieux I, Sorio R, Borsatti E, et al. Pharmacokinetics of vinorelbine in patients with liver metastases. Clin Pharmacol Ther. 1996 ; 59: 32-40 (Pubitemid 26046769)
37. Twelves CJ, O'Reilly SM, Coleman RE, Richards MA, Rubens RD. Weekly epirubicin for breast cancer with liver metastases and abnormal liver biochemistry. Br J Cancer. 1989 ; 60: 938-941 (Pubitemid 20024190)
38. Wilson WH, Berg SL, Bryant G, et al. Paclitaxel in doxorubicin-refractory or mitoxantrone-refractory breast cancer: a phase 1/II trial of 96-hour infusion. J Clin Oncol. 1994 ; 12: 1621-1629 (Pubitemid 24244998)
39. Heuff G, van der Ende MB, Boutkan H, et al. Macrophage populations in different stages of induced hepatic metastases in rats: an immunohistochemical analysis. Scand J Immunol. 1993 ; 38: 10-16 (Pubitemid 23196402)
40. Gulubova M, Manolova I, Cirovski G, Sivrev D. Recruitment of dendritic cells in human liver with metastases. Clin Exp Metastasis. 2008 ; 25: 777-785