Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients

Journal of Clinical Oncology

Volumn 15, Issue 4, 1997, Pages 1502-1510

  Gupta, E ^a   Mick, R ^a   Ramirez, J ^a   Wang, X ^a   Lestingi, T M ^a   Vokes, E E ^a   Ratain, M J ^a  

^a UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; DNA TOPOISOMERASE INHIBITOR; DRUG METABOLITE; IRINOTECAN; PARACETAMOL; PARACETAMOL GLUCURONIDE;

ARTICLE; CANCER; CLINICAL ARTICLE; DEMOGRAPHY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG ELIMINATION; DRUG GLUCURONIDATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG URINE LEVEL; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; PHARMACODYNAMICS; PHENOTYPE; PRIORITY JOURNAL;

EID: 0030958098     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1997.15.4.1502     Document Type: Article

References (51)

1. Kaneda N, Nagata H, Furuta T, et al: Metabolism and pharmacokinetics of the camptothecin analogue CPT-11 in the mouse. Cancer Res 50:1715-1720, 1990
2. Tsuji T, Kaneda N, Kado K, et al: CPT-11 converting enzyme from rat serum: Purification and some properties. J Pharmacobiodyn 14:341-349, 1991
3. Atsumi R, Suzuki W, Hakusui H: Identification of the metabolites of irinotecan, a new derivative of camptothecin, in rat bile and its biliary excretion. Xenobiotica 21:1159-1169, 1991
4. Kaneda N, Yokokura T: Nonlinear pharmacokinetics of CPT-11 in rats. Cancer Res 50:1721-1725, 1990
5. Rivory LP, Riou JF, Haaz M-CH, et al: Identification and properties of a major metabolite of irinotecan (CPT-11) isolated from the plasma of patients. Cancer Res 56:3689-3694, 1996
6. Kawato Y, Aonuma M, Hirota Y, et al: Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res 51: 4187-4191, 1991
7. Gupta E, Lestingi TM, Mick R, et al: Metabolic fate of irinotecan in humans: Correlation of glucuronidation with diarrhea. Cancer Res 54:3723-3725, 1994
8. Rivory LP, Robert J: Identification and kinetics of a β glucuronide metabolite of SN-38 in human plasma after administration of the camptothecin derivative irinotecan. Cancer Chemother Pharmacol 36:176-179, 1995
9. Lokiec F, Canal P, Gay C, et al: Pharmacokinetics of irinotecan and its metabolites in human blood, bile and urine. Cancer Chemother Pharmacol 36:79-82, 1995
10. Negoro S, Fukuoka M, Masuda N, et al: Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst 83:1164-1168, 1991
11. Ohe Y, Sasaki Y, Shinkai T, et al: Phase I study and pharmacokinetics of CPT-11 with 5-day continuous infusion. J Natl Cancer Inst 84:972-974, 1992
12. Rothenberg ML, Kuhn JG, Burris III HA, et al: Phase I and pharmacokinetic trial of weekly CPT-11. J Clin Oncol 11:2194-2204, 1993
13. Rowinsky EK, Grochow LB, Ettinger DS, et al: Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every 3 weeks. Cancer Res 54:427-436, 1994
14. de Forni M, Bugat R, Chabot GG, et al: Phase I and pharmacokinetic study of the camptothecin derivative irinotecan administered on a weekly schedule in cancer patients. Cancer Res 54:4347-4354, 1994
15. Catimel G, Chabot GG, Guastalla JP, et al: Phase I and pharmacokinetic study of irinotecan (CPT-11) administered daily for three consecutive days every three weeks in patients with advanced solid tumors. Ann Oncol 6:133-140, 1995
16. Abigerges D, Chabot GG, Armand J-P, et al: Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 13:210-221, 1995
17. Chabot GG, Abigerges D, Catimel G, et al: Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials. Ann Oncol 6:141-151, 1995
18. Sasaki Y, Hakusui H, Mizuno S, et al: A pharmacokinetic and pharmacodynamic analysis of CPT-11 and its active metabolite SN-38. Jpn J Cancer Res 86:101-110, 1995
19. Mick R, Ratain MJ: Statistical approaches to pharmacodynamic modeling: Motivations, methods and misperceptions. Cancer Chemother Pharmacol 33:1-9, 1993
20. De Morais SMF, Wells PG: Enhanced acetaminophen metabolism in Caucasians and Orientals. Hepatology 10:163-167, 1989
21. Hjelle JJ: Hepatic UDP-glucuronic acid regulation during acetaminophen biotransformation in rats. J Pharmacol Exp Ther 237:750-756, 1986
22. Critchley JAJH, Nimmo GR, Gregson CA, et al: Inter-subject and ethnic differences in paracetamol metabolism. Br J Clin Pharmacol 22:649-657, 1986
23. Mucklow JC, Fraser HS, Bulpitt CJ, et al: Environmental factors affecting paracetamol metabolism in London factory and office workers. Br J Clin Pharmacol 10:67-74, 1980
24. Bock KW, Wiltfang J, Blume R, et al: Paracetamol as a test drug to determine glucuronide formation in man. Effects of inducers and of smoking. Eur J Clin Pharmacol 31:677-683, 1987
25. Prescott LF, Critchley JAJH, Balali-Mood M, et al: Effects of microsomal enzyme induction on paracetamol metabolism in man. Br J Clin Pharmacol 12:149-153, 1981
26. Bock KW, Schrenk D, Forster A, et al: The influence of environmental and genetic factors on CYP2D6, CYP1A2, and UDP-glucuronosyltransferases in man using sparteine, caffeine and paracetamol as probes. Pharmacogenetics 4:209-218, 1994
27. Miners JO, Attwood J, Birkett DJ: Determinants of acetaminophen metabolism: Effect of inducers and inhibitors of drug metabolism on acetaminophen's metabolic pathways. Clin Pharmacol Ther 35:480-486, 1984
28. Howie D, Adriaenssens PI, Prescott LF: Paracetamol metabolism following overdosage: Application for high performance liquid chromatography. J Pharm Pharmacol 29:235-237, 1977
29. Gibaldi M: Compartmental and noncompartmental pharmacokinetics, in Biopharmaceutics and Clinical Pharmacokinetics (ed 4). Philadelphia, PA, Lea & Febiger, 1991, pp 14-23
30. Ullrich D, Sieg A, Blume R, et al: Normal pathways of glucuronidation, sulphation and oxidation of paracetamol in Gilbert's syndrome. Eur J Clin Invest 17:237-240, 1987
31. Hollander A, Wolfe DA: Non-parametric Statistical Methods. New York, NY, Wiley, 1993, pp 120-123
32. Burke TG, Munshi CB, Mi Z, et al: The important role of albumin in determining the relative human blood stabilities of the camptothecin anticancer drugs. J Pharm Sci 84:518-519, 1995
33. Divoll M, Greenblatt DJ, Harmatz JS, et al: Effect of age and gender on disposition of temazepam. J Pharm Sci 70:1104-1107, 1981
34. Yue Q-Y, Svensson J-O, Sawe J, et al: Codeine metabolism in three Oriental populations: A pilot study in Chinese, Japanese and Koreans. Pharmacogenetics 5:173-177, 1995
35. Patel M, Tang BK, Kalow W: Variability of acetaminophen metabolism in Caucasians and Orientals. Pharmacogenetics 2:38-45, 1992
36. Greenblatt DJ, Divoll M, Harmatz JS, et al: Oxazepam kinetics: Effects of age and sex. J Pharmacol Exp Ther 215:86-91, 1980
37. Iyer L, Roy SK, Ratain MJ: In vitro glucuronidation of SN-38, the active metabolite of irinotecan (CPT-11) in human liver microsomes. Proc Am Soc Clin Oncol 15:497, 1996 (abstr)
38. Atsumi R, Okazaki O, Hakusui H: Pharmacokinetics of SN-38 [(+)-(4S)-4,11-diethyl-4,9-dihydroxy-1H-pyrano[3′,4′:6,7]- indolizino[1,2-b]quinoline-3,14(4H,12H)-dione], an active metabolite of irinotecan, after a single intravenous dosing of 14C-SN-38 to rats. Biol Pharm Bull 18:1114-1119, 1995
39. Satoh T, Hosokawa M, Atsumi R, et al: Metabolic activation of CPT-11, 7-ethyl-10-[-4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin, a novel antitumor agent by carboxylesterase. Biol Pharm Bull 17:662-664, 1994
40. Wooster R, Ebner T, Sutherland L, et al: Drug and xenobiotic glucuronidation catalyzed by cloned human liver UDP-glucuronosyltransferases stably expressed in tissue culture cell lines. Toxicology 82:119-129, 1993
41. Burchell B, Ebner T, Baird S, et al: Use of cloned and expressed human liver UDP-glucuronosyltransferases for analysis of drug glucuronide formation and assessment of drug toxicity. Environ Health Perspect 102:19-23, 1994
42. Ritter JK, Crawford JM, Owens IS: Cloning of two human liver bilirubin UDP-glucuronosyltransferase cDNAs with expression in COS-1 cells. J Biol Chem 266:1043-1047, 1991
43. Inaba T, Nebert DW, Burchell B, et al: Pharmacogenetics in clinical pharmacology and toxicology. Can J Physiol Pharmacol 73:331-338, 1995
44. Daly AK, Cholerton S, Gregory W, et al: Metabolic polymorphisms. Pharmacol Ther 57:129-160, 1993
45. Mick R, Gupta E, Vokes EE, et al: Limited sampling models for irinotecan pharmacokinetics-pharmacodynamics: Prediction of biliary index and intestinal toxicity. J Clin Oncol 14:2012-2019, 1996
46. Burchell B, Nebert DW, Nelson DR, et al: The UDP glucuronosyl transferase gene superfamily: Suggested nomenclature based on evolutionary divergence. DNA Cell Biol 10:487-494, 1991
47. Iyer L, Whitington P, Roy SK et al: Genetic basis for the glucuronidation of SN-38: Role of UGT*1 isoform. Clin Pharmacol Ther (in press)
48. Araki E, Ishikawa M, Iigo M, et al: Relationship between development of diarrhea and the concentration of SN-38, an active metabolite of CPT-11, in the intestine and the blood plasma of athymic mice following intraperitoneal administration of CPT-11. Jpn J Cancer Res 84:697-702, 1993
49. Ikuno N, Soda H, Watanabe M, et al: Irinotecan (CPT-11) and characteristic mucosal changes in the mouse ileum and cecum. J Natl Cancer Inst 87:1876-1883, 1995
50. Gupta E, Safa AR, X Wang, et al: Pharmacokinetic modulation of irinotecan and metabolites by cyclosporine A. Cancer Res 56:1309-1314, 1996
51. Gupta E, Wang X, Ratain MJ: Modulation of glucuronidation of SN-38, the active metabolite by irinotecan, by valproic acid and phenobarbital. Cancer Chemother Pharmacol (in press)