Pharmacokinetics and pharmacodynamics of irinotecan during a phase II clinical trial in colorectal cancer

Journal of Clinical Oncology

Volumn 14, Issue 10, 1996, Pages 2688-2695

  Canal, P ^a   Gay, C ^a   Dezeuze, A ^a   Douillard, J Y ^a   Bugat, R ^a   Brunet, R ^a   Adenis, A ^a   Herait, P ^a   Lokiec, F ^a   Mathieu Boue, A ^a  

^a INSTITUT CLAUDIUS REGAUD   (France)

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; IRINOTECAN;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; DRUG GLUCURONIDATION; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 0010917253     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.10.2688     Document Type: Article

References (43)

1. Kunimoto T, Nitta K, Tanaka Y, et al: Antitumor activity of inhibitor 7-ethyl-10-[4-(1-piperidino)-1-piperidino]-carbonyloxy-camptothecin, a novel water-soluble derivative of camptothecin against murine tumors. Cancer Res 47:5944-5947, 1987
2. Matzusaki T, Yokokura T, Mutai M, et al: Inhibition of spontaneous and experimental metastasis by a new derivative of camptothecin, CPT-11, in mice. Cancer Chemother Pharmacol 21:308-312, 1988
3. Houghton PJ, Cheshire PJ, Hallman JC, et al: Therapeutic efficacy of the topoisomerase I inhibitor 7-ethyl- 10-[4-(1-piperidino)-1-piperidino]-carbonyloxy-camptothecin against human tumor xenografts: Lack of cross-resistance in vivo in tumors with acquired resistance to the topoisomerase inhibitor 9-dimethylaminomethly-10-hydroxycamptothecin. Cancer Res 53:2823-2829, 1993
4. Tsuruo T, Matsuzaki T, Matsushita M, et al: Antitumor effect of CPT-11, a new derivative of camptothecin against pleiotropic drug-resistant tumors in vitro and in vivo. Cancer Chemother Pharmacol 21:71-74, 1988
5. Hsiang YH, Hertzberg R, Hecht S, et al: Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J Biol Chem 260:14873-14878, 1985
6. Hsiang YH, Liu LF: Identification of mammalian DNA topoisomerase I as an intracellular target of the anticancer drug camptothecin. Cancer Res 48:1722-1726, 1988
7. Kessel D, Bosmann HB, Lohr K: Camptothecin effects on DNA synthesis in murine leukemia cells. Biochem Biophys Acta 269:210-216, 1972
8. Wang JC: DNA topoisomerase. Annu Rev Biochem 54:665-697, 1985
9. Hsiang YH, Liu LF, Wall M, et al: DNA topoisomerase I mediated DNA cleavage and cytotoxicity of camptothecin analogues. Cancer Res 49:4835-4839, 1989
10. Liu LF: DNA topoisomerase poisons as antitumor drugs. Annu Rev Biochem 58:351-375, 1989
11. Gupta RS, Gupta R, Eng B, et al: Camptothecin-resistant mutants of Chinese hamster ovary cells containing a resistant form of topoisomerase I. Cancer Res 48:6404-6410, 1988
12. Kanzawa F, Sugimoto Y, Minato K, et al: Establishment of a camptothecin analogue (CPT-11 )- resistant cell line of human small cell lung cancer: Characterization and mechanism of resistance. Cancer Res 50:5919-5924, 1990
13. Sugimoto Y, Tsukahara S, Oh-Hara T, et al: Decreased expression of DNA topoisomerase I in camptothecin-resistant tumor cell lines as determined by a monoclonal antibody. Cancer Res 50:6925-6930, 1990
14. Tamura H, Kohchi C, Yamada R: Molecular cloning of a cDNA of a camptothecin resistant human DNA topoisomerase I and identification of mutation sites. Nucleic Acid Res 51:1129-1136, 1991
15. Madeleine I, Prost S, Naudin A, et al: Sequential modifications of topoisomerase I activity in a camptothecin-resistant cell line established by progressive adaptation. Biochem Pharmacol 45:339-348, 1993
16. Kawato Y, Aonuma M, Hirato Y, et al: Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11 in the antitumour effect of CPT-11. Biochem Biophys Res Commun 188:70-77, 1992
17. Negoro S, Fukuoka M, Masuda N, et al: Phase I study of weekly intravenous infusions of CPT-11, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst 83:1164-1168, 1991
18. 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
19. Rothenberg ML, Kuhn JG, Burris H III, et al: Phase I and pharmacokinetic trial of weekly CPT-11. J Clin Oncol 11:2194-2204, 1993
20. 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 54:4347-4354, 1994
21. Rowinski 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
22. Abigerges D, Chabot GG, Armand JP, 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
23. Catimel G, Chabot GG, Guastalla JP, et al: Phase I and pharmacokinetic study of irinotecan (CPT-11) administered daily for three days every three weeks in patients with advanced solid tumors. Ann Oncol 6:133-140, 1995
24. 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
25. Chabot GG: Development of limited sampling models for the simultaneous estimation of irinotecan (CPT-11) and active metabolite SN-38 pharmacokinetics. Cancer Chemother Pharmacol 36:463-472, 1995
26. Barilero I, Gandia D, Armand JP, et al: Simultaneous determination of camptothecin analogue CPT-11 and its active metabolite SN-38 by high-performance liquid Chromatography : Applications to plasma pharmacokinetic studies in cancer patients. J Chromatogr Biomed Appl 575:275-280, 1992
27. 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
28. Rougier P, Culine S, Bugat R, et al: A phase II study of CPT-11 (irinotecan) in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with 5-FU-based chemotherapy. J Clin Oncol (in press)
29. Robert J, Vrignaud P, Nguyen-Ngoc T, et al: Comparative pharmacokinetics and metabolism of doxorubicin and epirubicin in patients with metastatic breast cancer. Cancer Treat Rep 69:633-640, 1985
30. Van der Vijgh WJF: Clinical pharmacokinetics of carboplatin. Clin Pharmacokinet 21:242-261, 1991
31. Kaneda N, Nagata H, Furuta T, et al: Metabolism and pharmacokinetics of the camptothecin analogue CPT-11 in the mouse. Cancer Res 50:1715-20, 1990
32. Atsumi R, Suzuki W, Hakusi H: Identification of the metabo lites of irinotecan, a new derivative of camptothecin, in rat bile and its biliary excretion. Xenobiotica 21:1159-1169, 1991
33. 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
34. Masuda N, Fukuoka M, Kodoh S, et al: Phase I and pharmacologic study of irinotecan in combination with cisplatin for advanced lung cancer. Br J Cancer 68:777-782, 1993
35. Masuda N, Fukuoka M, Kodoh S, et al: Phase I study of irinotecan and cisplatin with granulocyte colony-stimulating factor support for non-small-cell lung cancer. J Clin Oncol 12:90-96, 1994
36. 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
37. 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
38. Patel M, Tang BK, Kalow W: Variability of acetaminophen metabolism in Caucasians and Orientals. Pharmacogenetics 2:38-45, 1992
39. Evans WE, Crom WE, Abromowitch M, et al: Clinical pharmacodynamics of high-dose methotrexate in acute lymphoblastic leukemia. N Engl J Med 314:471-477, 1989
40. Lennard I, Lilleyman JS: Variable mercaptopurine metabolism and treatment outcome in childhood lymphoblastic leukemia. J Clin Oncol 7:1816-1823, 1987
41. Rodman JH, Abromowitch M, Sinkule JA, et al: Clinical pharmacodynamics of continuous infusion teniposide: Systemic exposure as a determinant of response in a phase I trial. J Clin Oncol 5:1007-1014, 1987
42. Jodrell DI, Egorin MJ, Canetta RM, et al: Relationships between carboplatin exposure and tumor response and toxicity in patients with ovarian cancer. J Clin Oncol 10:520-528, 1992
43. Egorin MJ: Therapeutic drug monitoring and dose optimisation in oncology, in Workman P (ed): New Approaches in Cancer Pharmacology: Drug Design and Development. Berlin, Germany, Springler-Verlag, 1992, pp 75-91