Pharmacokinetic, metabolic, and pharmacodynamic profiles in a dose- escalating study of irinotecan and cisplatin

Journal of Clinical Oncology

Volumn 18, Issue 1, 2000, Pages 195-203

  De Jonge, Maja J A ^a   Verweij, Jaap ^a   De Bruijn, Peter ^a   Brouwer, Eric ^a   Mathijssert, Ron H J ^a   Van Alphen, Robbert J ^a   De Boer Dennert, Maureen M ^a   Vernillet, Laurent ^a   Jacques, Christian ^a   Sparreboom, Alex ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; CISPLATIN; IRINOTECAN; PLATUSIN; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CANCER COMBINATION CHEMOTHERAPY; DNA REPAIR; DOSE CALCULATION; DRUG EFFECT; FEMALE; GLUCURONIDATION; HUMAN; MAJOR CLINICAL STUDY; MALE; METABOLIC REGULATION; MINIMUM INHIBITORY CONCENTRATION; PRIORITY JOURNAL; SOLID TUMOR;

EID: 0033987392     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.2000.18.1.195     Document Type: Article

References (39)

1. De Jonge MJA, Sparreboom A, Verweij J: The development of combination therapy involving camptothecins: A review of preclinical and early clinical studies. Cancer Treat Rev 24:205-220, 1998
2. Raymond E, Djelloul S, Buquet-Fagot C, et al: Oxaliplatin (LOHP) and cisplatin (CDDP) in combination with 5FU, specific thymidylate synthase (TS) inhibitors (AG337, ZD1694) and topoisomerase I (Topo-I) inhibitors (SN38, CPT-11), in human colonic, ovarian and breast cancers. Proc Am Assoc Cancer Res 37:291, 1996 (abstr 1981)
3. Goldwasser F, Bozec L, Zeghari-Squalli N, et al: Cellular pharmacology of the combination of oxaliplatin with topotecan in the IGROV-1 human ovarian cancer cell line. Anticancer Drugs 10:195-201, 1999
4. Goldwasser F, Valenti M, Torres R, et al: Potentiation of cisplatin cytotoxicity by 9-aminocamptothecin. Clin Cancer Res 2:687-693, 1996
5. Masuda N, Fukuoka M, Takada M, et al: CPT-11 in combination with cisplatin for advanced non-small-cell lung cancer. J Clin Oncol 10:1775-1780, 1992
6. Masuda N, Fukuoka M, Kudoh S, et al: Phase I and pharmacologie study of irinotecan in combination with cisplatin for advanced lung cancer. Br J Cancer 68:777-782, 1993
7. Sugiyama T, Takeuchi S, Noda K, et al: Phase I study of irinotecan (CPT-11) in combination with cisplatin (CDDP) on cervical carcinoma. Proc Natl Acad Sci U S A 13:268, 1994 (abstr 856)
8. Kobayashi K, Soma T, Shinbara A, et al: Phase I study of irinotecan (CPT-11) and cisplatin (CDDP) by divided administration in patients with non-small cell lung cancer (NSCLC). Proc Natl Acad Sci USA 15:388, 1996 (abstr 1169)
9. Shirao K, Shimada Y, Kondo H, et al: Phase I-II study of irinotecan hydrochloride combined with cisplatin in patients with advanced gastric cancer. J Clin Oncol 15:921-927, 1997
10. Ueoka H, Tabata M, Kiuraa K, et al: Fractionated administration of irinotecan and cisplatin for treatment of lung cancer: A phase I study. Br J Cancer 79:984-990, 1998
11. Mori K, Ohnishi T, Yokoyama K, et al: A phase I study of irinotecan and infusional cisplatin for advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 39:327-332, 1997
12. Saltz LB, Spriggs D, Schaaf LJ, et al: Phase I clinical and pharmacologic study of weekly cisplatin combined with weekly irinotecan in patients with advanced solid tumors. J Clin Oncol 16:3858-3865, 1998
13. Masuda N, Fukuoka M, Kudoh S, et al: Phase I study of irinotecan and cisplatin with granulocyte colony-stimulating factor support for advanced non-small-cell lung cancer. J Clin Oncol 12:90-96, 1994
14. Mori K, Hirose T, Machida S, et al: A phase I study of irinotecan and infusional cisplatin with recombinant human granulocyte colony-stimulating factor support in the treatment of advanced non-small cell lung cancer. Eur J Cancer 33:503-505, 1997
15. Sumiyoshi H, Fujiwara Y, Ohoshi N, et al: Clinical pharmacological evaluation of CPT-11 and cisplatin (CDDP) in patients with small cell lung cancer (SCLC). Proc Natl Acad Sci U S A 14:457, 1995 (abstr 1470)
16. Tsuji T, Kaneda N, Kado N, et al: CPT-11 converting enzyme from rat serum: Purification and some properties. J Pharmacobiodyn 14:341-349, 1991
17. Rivory LP, Bowles MR, Robert J, et al: Conversion of irinotecan (CPT-11) to its active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38), by human liver carboxylesterase. Biochem Pharmacol 52: 1103-1111, 1996
18. Zamboni WC, Houghton PJ, Thompson J, et al: Altered irinotecan and SN-38 disposition after intravenous and oral administation of irinotecan in mice bearing human neuroblastoma xenografts. Clin Cancer Res 4:455-462. 1998
19. Danks MK, Morton CL, Pawlik CA, et al: Overexpression of a rabbit liver carboxylesterase sensitizes human tumor cells to CPT-11. Cancer Res 58:20-22. 1998
20. Atsumi R, Okazaki O, Hakusui H: Metabolism of irinotecan to SN-38 in a tumor-isolated tumor model. Biol Pharm Bull 18:1024-1026, 1995
21. Rivory LP, Robert J: Identification and kinetics of a betaglucuronide metabolite of SN-38 in human plasma after administration of the camptothecin derivative irinotecan. Cancer Chemother Pharmacol 36:176-179, 1995
22. Haaz MC, Rivory LP, Jantet S, et al: Glucuronidation of SN-38. the active metabolite of irinotecan, by human hepatic microsomes. Pharmacol Toxicol 80:91-95, 1997
23. Lokiec F, Monegier du Sorbier B, Sanderink GJ: Irinotecan (CPT-11) metabolites in human bile and urine. Clin Cancer Res 2:1943-1949, 1996
24. Rivory LP, Riou JF, Haaz MC, et al: Identification and properties of a major plasma metabolite of irinotecan (CPT-11) isolated from the plasma of patients. Cancer Res 56:3689-3694, 1996
25. Dodds HM, Haaz MC, Riou JF, et al: Identification of a new metabolite of CPT-11 (irinotecan): Pharmacological properties and activation to SN-38. J Pharmacol Exp Ther 286:578-583, 1998
26. De Jonge MJA, Sparreboom A, Planting AST, et al: Phase I study of 3-weekly irinotecan combined with cisplatin in patients with advanced solid tumors. J Clin Oncol 18:187-194, 2000
27. De Bruijn P, Verweij J, Loos WJ, et al: Determination of irinotecan (CPT-11) and its active metabolite SN-38 in human plasma by reversed-phase high-performance liquid chromatography with fluorescence detection. J Chromatogr B Biomed Sci App 698:277-285, 1997
28. Sparreboom A, De Bruijn P, De Jonge MJA, et al: Liquid Chromatographic determination of irinotecan and three major metabolites in human plasma, urine and feces. J Chromatogr B Biomed Sci App 712:225-235, 1998
29. Reed E, Sauerhoff S, Poirier MC: Quantitation of platinum-DNA binding after therapeutic levels of drug exposure: A novel use of graphite furnace spectrometry. Atom Spectr 9:93-95, 1988
30. Ma J, Verweij J, Planting AST, et al: Current sample handling methods for measurement of platinum-DNA-adducts in leukocytes in man lead to discrepant results in DNA-adduct levels and DNA-repair. Br J Cancer 71:512-517, 1995
31. Ma J, Stoter G, Verweij J, et al: Comparison of ethanol plasma protein precipitation with plasma ultrafiltration and trichloroacetic acid protein precipitation for the measurement of unbound platinum concentration. Cancer Chemother Pharmacol 38:391-394, 1996
32. Sparreboom A, De Jonge MJA, De Bruijn P, et al: Irinotecan (CPT-11) metabolism and disposition in cancer patients. Clin Cancer Res 4:2747-2754, 1998
33. Rivory LP, Haaz MC, Canal P, et al: Pharmacokinetic interrelationships of irinotecan (CPT-11) and its three major metabolites in patients enrolled in phase I/II trials. Clin Cancer Res 3:1261-1266, 1997
34. Schellens JHM, Ma J, Planting AST, et al: Relationship between the exposure to cisplatin, DNA-adduct formation in leukocytes and tumour response in patients with solid tumours. Br J Cancer 73:1569-1575, 1996
35. Holford NHG, Sheiner LB: Understanding the dose-effect relationship: Clinical application of pharmacokinetic-pharmacodynamic models. Clin Pharmacokinet 6:429-453, 1981
36. 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
37. 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
38. Canal P, Gay C, Dezeuze A, et al: Pharmacokinetics and pharmacodynamics of irinotecan during a phase II clinical trial in colorectal cancer. J Clin Oncol 14:2688-2695, 1996
39. Rivory LP, Chatelut E, Canal P, et al: Kinetics of the in vivo interconversion of the carboxylate and lactone forms of irinotecan (CPT-11) and of its metabolite SN-38 in patients. Cancer Res 54:6330-6333, 1994