Limited-sampling models for irinotecan pharmacokinetics- pharmacodynamics: Prediction of biliary index and intestinal toxicity

Journal of Clinical Oncology

Volumn 14, Issue 7, 1996, Pages 2012-2019

  Mick, R ^a   Gupta, E ^a   Vokes, E E ^a   Ratain, M J ^a  

^a UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; IRINOTECAN;

ADULT; ARTICLE; CANCER; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; ENTEROPATHY; FEMALE; HUMAN; MALE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 0029902106     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.7.2012     Document Type: Article

References (22)

1. 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
2. Atsumi R, Suzuki W, Hakusui H: Identification of the metabolites of irinotecan, a new derivative of camptothecin, in rat bile and its biliary excretion. Xenobiot 21:1159-1169, 1991
3. Gupta E, Lestingi TM, Mick R, et al: Metabolite fate of irinotecan (CPT-11) in humans: Correlation of glucuronidation with diarrhea. Cancer Res 54:3723-3725, 1994
4. 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
5. 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
6. Negoro S, Fukuoka M, Masuda N, et al: Phase I 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
7. Rowinsky EK, Grochow LB, Ettinger DS, et al: Phase I and pharmacologic study of the novel topoisomerase I inhibitor 7-ethyl10-[4-(1-piperidino)-1-piperidino] carbonyloxycamptothecin (CPT-11) administered as a 90-minute infusion every 3 weeks. Cancer Res 54:427-456, 1994
8. de Forni M, Bugat R, Chabot GG, et al: Phase I and pharmacokinetic study of the camptothecin derivative irinotecan administered as a weekly schedule in cancer patients. Cancer Res 54:4347-4354, 1994
9. Catimel G, Chabot GG, Guastalla JP, et al: Phase I and pharmacokinetic study of irinotecan (CPT-11) administered daily for 3 consecutive days every 3 weeks in patients with advanced solid tumors. Ann Oncol 6:133-140, 1995
10. 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
11. 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
12. 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
13. Ikuno N, Soda H, Wantanabe M, et al: Irinotecan (CPT-11) and characteristic mucosal changes in the mouse ileum and cecum. Natl Cancer Inst 87:1876-1883, 1995
14. Gupta E, Mick R, Wang X, et al: Pharmacokinetic-pharmacodynamic (PK-PD) analysis of intestinal toxicity associated with irinotecan (CPT-11): Validation of the biliary index (BI). Clin Pharmacol Ther 59:197, 1996 (abstr)
15. Draper H, Smith H: Applied Regression Analysis. New York, NY, Wiley, 1981, pp 70-107
16. Hocking RR: Analysis and selection of variables in linear regression. Biometrics 32:1-49, 1976
17. Snedecor GE, Cochran WG: Statistical Methods (ed 7). Ames, IA, Iowa State University, 1980
18. Sheiner LB, Beal SL: Scientific commentary. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 9:503-512, 1981
19. Hollander M, Wolfe DA: Nonparametric Statistical Methods. New York, NY, Wiley, 1973
20. Sasaki Y, Mizuno S, Fujii H, et al: A limited sampling model for estimating pharmacokinetics of CPT-11 and its metabolite SN-38. Jpn J Cancer Res 86:117-123, 1995
21. Chabot GG: Limited sampling models for simultaneous estimation of the pharmacokinetics of irinotecan and its active metabolite SN-38. Cancer Chemother Pharmacol 36:463-472, 1995
22. Gupta E, Safa AR, Wang X, et al: Pharmacokinetic modulation of irinotecan and metabolites by cyclosporine A. Cancer Res 56:1309-1314, 1996