Doxorubicin encapsulated in liposomes containing surface-bound polyethylene glycol: Pharmacokinetics, tumor localization, and safety in patients with AIDS-related Kaposi's sarcoma

Journal of Clinical Pharmacology

Volumn 36, Issue 1, 1996, Pages 55-63

  Northfelt, Donald W ^a,b,d   Martin, Francis J ^c   Working, Peter ^c   Volberding, Paul A ^a,b   Russell, Julie ^a,b   Newman, Mary ^c   Amantea, Michael A ^c   Kaplan, Lawrence D ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b SAN FRANCISCO GENERAL HOSPITAL   (United States)

^c ALZA CORPORATION   (United States)

^d Pacific Oaks Medical Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DAUNORUBICIN; DOXORUBICIN; DOXORUBICINOL; LIPOSOME; MACROGOL;

ADULT; AIDS RELATED COMPLEX; ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER LOCALIZATION; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; FATIGUE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; KAPOSI SARCOMA; MALE; NAUSEA; NEUTROPENIA; RANDOMIZED CONTROLLED TRIAL; STOMATITIS;

EID: 0030024958     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.1996.tb04152.x     Document Type: Article

References (35)

1. Beral V, Peterman TA, Berkelman RL, Jaffe HN: Kaposi's sarcoma among persons with AIDS: a sexually transmitted infection? Lancet 1990;1:123-128.
2. Miles SA, Wang H, Elashoff R, Mitsuyasu RT: Improved survival for patients with AIDS-related Kaposi's sarcoma. J Clin Oncol 1994;12:1910-1916.
3. Gill PS, Akil B, Colletti P, Rarick M, Lovreivo C, Bernstein-Singer M, et al: Pulmonary Kaposi's sarcoma: clinical findings and results of therapy. Am J Med 1989;87:57-61.
4. Plettenberg A, Stoehr A, van Dyk U, Albrecht H, Stellbrink HJ, Meigel W: Increasing risk for opportunistic infections (CDC IV C1) during chemotherapy in patients with Kaposi's sarcoma (abstract). IX International Conference on AIDS, Berlin, July 12-18 1993;PO-B12-1557.
5. Gabizon A, Chisin R, Amselem S, Druckmann S, Cohen R, Goren D, et al: Pharmacokinetic and imaging studies in patients receiving a formulation of liposome-associated Adriamycin. Br J Cancer 1991;64:1125-1132.
6. Gabizon A, Barenholz Y, Bialer M: Prolongation of circulation time of doxorubicin encapsulated in liposomes containing a polyethylene glycol-derivatized phospholipid: pharmacokinetic studies in rodents and dogs. Pharm Res 1993;10:703-708.
7. Huang SK, Mahew E, Gilani S: Pharmacokinetics and therapeutics of sterically stabilized liposomes in mice bearing C-26 colon carcinoma. Cancer Res 1992;52:6774-6781.
8. Huang SK, Martin FJ, Jay G, Vogel J, Papahadjopoulos D, Friend DS: Extravasation and transcytosis of liposomes in Kaposi's sarcoma-like dermal lesions of transgenic mice bearing the HIV tat gene. Am J Pathol 1993;143:10-14.
9. Vaage J, Barbera-Guillem E, Abra R, Huang A, Working P: Tissue distributions and therapeutic effects of intravenous free and liposomal doxorubicin against human prostatic carcinoma xenografts. Cancer 1994;73:2366-2371.
10. Krown SE, Metroka C, Wernz JC: Kaposi's sarcoma in the acquired immunodeficiency syndrome: a proposal for uniform evaluation, response, and staging criteria. J Clin Oncol 1989;7:1201-1207.
11. World Health Organization: Handbook for Reporting Results of Cancer Treatment. Offset Publication No. 48. Geneva, Switzerland: World Health, Organization, 1979.
12. De Groot G, Tepas BCA, Storm G: High-performance liquid chromatographic determination of doxorubicin in tissues after solid phase extraction. J Pharm Biomed Anal 1988:6:927-932.
13. De Jong J, Maessen PA, Akkerdaas A, Cheung SF, Pinedo HM, vander Vigh WJ: Sensitive method for the determination of daunorubicin and all its known metabolites in plasma and heart by high-performance liquid chromatography with fluorescence detection. J Chromatogr 1990;529:359-368.
14. Prévost G: Estimation of a normal probability density function from samples measured with non-neglible and non-constant dispersion (internal report). Palaiseau, France: Adersa Gerbios, 1977.
15. Stiemer JL, Mallet A, Golmard J, Boisieux J: Alternative approaches to estimation of population pharmacokinetic parameters: comparison with the nonlinear mixed effect model. Drug Metab Rev 1984;15:265-292.
16. Sheiner LB: The population approach to pharmacokinetic data analysis: rationale and standard data analysis methods. Drug Metab Rev 1984;15:153-171.
17. D'Argenio DZ, Schumitzky A: A program package for simulation and parameter estimation in pharmacokinetic systems. Comput Progr Biomed 1979;9:115-134.
18. D'Argenio DZ, Schumitzky A: Adapt Users Guide. Los Angeles: Biomedical Simulations Resource, UCLA, 1992.
19. Jusko WJ: Guidelines for collection and analysis of pharmacokinetic data. In, Evans WE, Jusko WJ, Schentag JJ (eds.): Applied Pharmacokinefics: Principles of Therapeutic Drug Monitoring. Third edition. Vancouver, WA: Applied Therapeutics, 1992:1-43.
20. Akaike HA: Bayesian extension of the minimum AIC procedure of autoregressive model fitting. Biometika 1979;66:237-242.
21. Speth PAJ, van Hoesel QGCM, Haanen C: Clinical pharmacokinetics of doxorubicin. Clin Pharmacokinet 1988;15:15-31.
22. Greene RF, Collins JM, Jenkins JF, Speyer JL, Myers CE: Plasma pharmacokinetics of adriamycin and adriamycinol: implications for the design of in vitro experiments and treatment protocols. Cancer Res 1983;43:3417-3421.
23. Speth PAJ, Linssen PCM, Holdrinet RSG, Haanen G: Plasma and cellular adriamycin concentrations in patients with myeloma treated with 96-hour continuous infusions. Clin Pharmacol Ther 1987;41:661-665.
24. Landaw EM, DiStefane JJ: Multiexponential, multicompartment, and noncompartmental modeling. II. Data analysis and statistical considerations. Am J Physiol 1984;15:R665-R677.
25. Gabizon A, Catane R, Uziely B, Kaufman B, Safra T, Cohen R, et al: Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethyleneglycol coated liposomes. Cancer Res 1994;54:987-992.
26. DiFronzo G, Lenaz L, Bonadonna G: Distribution and excretion of adriamycin in man. Biomedicine 1973;19:169-171.
27. Timour Q, Nony P, Lang J, Lakhal M, Trillet V, Faucon G: Doxorubicin concentration time course in the myocardium after a single administration to the dog. Cancer Chemother Pharm 1987;20: 267-269.
28. Cummings J, McArdle CS: Studies on the in vivo disposition of adriamycin in human tumors which exhibit different responses to the drug. Br J Cancer 1986;53:835-838.
29. Lee YN, Chan KK, Harris PA, Cohen JL: Distribution of adriamycin in cancer patients, tissue uptakes, plasma concentrations after intravenous and hepatic intraarterial administration. Cancer 1980;45:2231-2239.
30. Northfelt DW: "Stealth" liposomal doxorubicin (SLD) delivers more doxorubicin to AIDS-Kaposi's Sarcoma lesions than to normal skin (abstract). Proc Am Soc Clin Ortcol 1994;13:51.
31. Huang SK, Lee KD, Hong K, Friend DS, Papahadjopolous D: Microscopic localization of sterically stabilized liposomes in colon carcinoma-bearing mice. Cancer Res 1992;52:5135-5143.
32. Shubik P: Vascularization of tumors: a review. J Cancer Res Clin Oncol 1982;103:211-226.
33. Dvorak H, Nagy JA, Dvorak JT, Dvorak AM: Identification and characterization of the blood vessels of solid tumors that are leaky to circulating macromolecules. Am J Pathol 1988;133:95-109.
34. Seymour LW: Passive tumor targeting of soluble macromolecules and drug conjugates. Crit Rev Ther Drug Carrier Syst 1992;9: 135-187.
35. Vogel J, Henricks SH, Reynolds RK, Luciw PA, Jay G: The HIV tat gene induces dermal lesions resembling Kaposi's sarcoma in transgenic mice. Nature 1988;335:606-611.