DE-310, a macromolecular prodrug of the topoisomerase-I-inhibitor exatecan (DX-8951), in patients with operable solid tumors

Investigational New Drugs

Volumn 23, Issue 4, 2005, Pages 339-347

  Wente, Moritz N ^a   Kleeff, Jörg ^a   Büchler, Markus W ^a   Wanders, Jantien ^b   Cheverton, Peter ^b   Langman, Stephen ^b   Friess, Helmut ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b Daiichi Pharmaceuticals UK Ltd   (United Kingdom)

Author keywords

Camptothecins; Macromolecular prodrugs; Tissue distribution; Topoisomerase I inhibitors

Indexed keywords

ANTINEOPLASTIC AGENT; DE 310; DNA TOPOISOMERASE INHIBITOR; EXATECAN; GLYCYL EXATECAN; PRODRUG; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; BLOOD SAMPLING; CANCER PATIENT; CANCER SURGERY; CANCER TISSUE; CLINICAL ARTICLE; CLINICAL OBSERVATION; DISEASE SEVERITY; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CONJUGATION; DRUG DETERMINATION; DRUG DISTRIBUTION; DRUG EXPOSURE; DRUG INFUSION; DRUG SCREENING; DRUG TISSUE LEVEL; HUMAN; HUMAN TISSUE; MACROMOLECULE; MALE; NAUSEA; PLASMA; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SLOW DRUG RELEASE; SOLID TUMOR;

AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; AREA UNDER CURVE; CAMPTOTHECIN; DELAYED-ACTION PREPARATIONS; DNA TOPOISOMERASES, TYPE I; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; NEOPLASMS; PRODRUGS; TISSUE DISTRIBUTION;

EID: 22144494957     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-005-1442-2     Document Type: Article

References (44)

1. Wall ME, Wani MC, Cook CE, Palmer KH: Plant antitumour agents, I: The isolation and structure of camptothecin, a novel alkaloidal leukemia and tumor inhibitor of Camptotheca acuminata. J Am Chem Soc 88: 3888-3890, 1966
2. Garcia-Carbonero R, Supko JG: Current perspectives on the clinical experience, pharmacology, and continued development of the camptothecins. Clin Cancer Res 8: 641-661, 2002
3. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355: 1041-1047, 2000
4. Drengler RL, Kuhn JG, Schaaf LJ, Rodriguez GI, Villalona-Calero MA, Hammond LA, Stephenson JA, Jr., Hodges S, Kraynak MA, Staton BA, Elfring GL, Locker PK, Miller LL, Von Hoff DD, Rothenberg ML: Phase I and pharmacokinetic trial of oral irinotecan administered daily for 5 days every 3 weeks in patients with solid tumors. J Clin Oncol 17: 685-696, 1999
5. Rothenberg ML, Kuhn JG, Burris HA, III, Nelson J, Eckardt JR, Tristan-Morales M, Hilsenbeck SG, Weiss GR, Smith LS, Rodriguez GI: Phase I and pharmacokinetic trial of weekly CPT-11. J Clin Oncol 11: 2194-2204, 1993
6. Rougier P, Van Cutsem E, Bajetta E, Niederle N, Possinger K, Labianca R, Navarro M, Morant R, Bleiberg H, Wils J, Awad L, Herait P, Jacques C: Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 352: 1407-1412, 1998
7. van Warmerdam LJ, Bokkel Huinink WW, Rodenhuis S, Koier I, Davies BE, Rosing H, Maes RA, Beijnen JH: Phase I clinical and pharmacokinetic study of topotecan administered by a 24-hour continuous infusion. J Clin Oncol 13: 1768-1776, 1995
8. Creemers GJ, Gerrits CJ, Schellens JH, Planting AS, van der Burg ME, van Beurden VM, Boer-Dennert M, Harteveld M, Loos W, Hudson I, Stoter G, Verweij J: Phase II and pharmacologic study of topotecan administered as a 21-day continuous infusion to patients with colorectal cancer. J Clin Oncol 14: 2540-2545, 1996
9. Takimoto CH, Morrison G, Harold N, Quinn M, Monahan BP, Band RA, Cottrell J, Guemei A, Llorens V, Hehman H, Ismail AS, Flemming D, Gosky DM, Hirota H, Berger SJ, Berger NA, Chen AP, Shapiro JD, Arbuck SG, Wright J, Hamilton JM, Allegra CJ, Grem JL: Phase I and pharmacologic study of irinotecan administered as a 96-hour infusion weekly to adult cancer patients. J Clin Oncol 18: 659-667, 2000
10. Conover CD, Greenwald RB, Pendri A, Gilbert CW, Shum KL: Camptothecin delivery systems: Enhanced efficacy and tumor accumulation of camptothecin following its conjugation to polyethylene glycol via a glycine linker. Cancer Chemother Pharmacol 42: 407-414, 1998
11. Rowinsky EK, Rizzo J, Ochoa L, Takimoto CH, Forouzesh B, Schwartz G, Hammond LA, Patnaik A, Kwiatek J, Goetz A, Denis L, McGuire J, Tolcher AW: A phase I and pharmacokinetic study of pegylated camptothecin as a 1-hour infusion every 3 weeks in patients with advanced solid malignancies. J Clin Oncol 21: 148-157, 2003
12. Schoemaker NE, van Kesteren C, Rosing H, Jansen S, Swart M, Lieverst J, Fraier D, Breda M, Pellizzoni C, Spinelli R, Grazia PM, Beijnen JH, Schellens JH, Bokkel Huinink WW: A phase I and pharmacokinetic study of MAG-CPT, a water-soluble polymer conjugate of camptothecin. Br J Cancer 87: 608-614, 2002
13. Joto N, Ishii M, Minami M, Kuga H, Mitsui I, Tohgo A: DX-8951f, a water-soluble camptothecin analog, exhibits potent antitumor activity against a human lung cancer cell line and its SN-38-resistant variant. Int J Cancer 72: 680-686, 1997
14. Sun FX, Tohgo A, Bouvet M, Yagi S, Nassirpour R, Moossa AR, Hoffman RM: Efficacy of camptothecin analog DX-8951f (Exatecan Mesylate) on human pancreatic cancer in an orthotopic metastatic model. Cancer Res 63: 80-85, 2003
15. De Jager R, Cheverton P, Tamanoi K, Coyle J, Ducharme M, Sakamoto N, Satomi M, Suzuki M: DX-8951f: summary of phase I clinical trials. Ann N Y Acad Sci 922: 260-273, 2000
16. Braybrooke JP, Ranson M, Manegold C, Mattson K, Thatcher N, Cheverton P, Sekiguchi M, Suzuki M, Oyama R, Talbot DC: Phase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer. Lung Cancer 41: 215-219, 2003
17. Esteva FJ, Rivera E, Cristofanilli M, Valero V, Royce M, Duggal A, Colucci P, DeJager R, Hortobagyi GN: A Phase II study of intravenous exatecan mesylate (DX-8951f) administered daily for 5 days every 3 weeks to patients with metastatic breast carcinoma. Cancer 98: 900-907, 2003
18. Royce ME, Rowinsky EK, Hoff PM, Coyle J, DeJager R, Pazdur R, Saltz LB: A Phase II study of intravenous exatecan mesylate (DX-8951f) administered daily for five days every three weeks to patients with metastatic adenocarcinoma of the colon or rectum. Invest New Drugs 22: 53-61, 2004
19. Verschraegen CF, Kudelka AP, Hu W, Vincent M, Kavanagh JJ, Loyer E, Bastien L, Duggal A, De Jager R: A phase II study of intravenous exatecan mesylate (DX-8951f) administered daily for 5 days every 3 weeks to patients with advanced ovarian, tubal or peritoneal cancer resistant to platinum, taxane and topotecan. Cancer Chemother Pharmacol 53: 1-7, 2004
20. Inoue K, Kumazawa E, Kuga H, Susaki H, Masubuchi N, Kajimura T: CM-dextran-polyalcohol-camptothecin conjugate: DE-310 with a novel carrier system and its preclinical data. Adv Exp Med Biol 519: 145-153, 2003
21. Maeda H, Matsumura Y: Tumoritropic and lymphotropic principles of macromolecular drugs. Crit Rev Ther Drug Carrier Syst 6: 193-210, 1989
22. Maeda H, Wu J, Sawa T, Matsumura Y, Hori K: Tumor vascular permeability and the EPR effect in macromolecular therapeutics: A review. J Control Release 65: 271-284, 2000
23. Maeda H: The enhanced permeability and retention (EPR) effect in tumor vasculature: The key role of tumor-selective macromolecular drug targeting. Adv Enzyme Regul 41: 189-207, 2001
24. Soepenberg O, de Bruijn P, Verweij J, Atsumi R, Sparreboom A: Liquid chromatographic assays for DE-310, a novel camptothecin analog, and two major enzymatic products in human matrices. J Chromatogr B Analyt Technol Biomed Life Sci 799: 15-22, 2004
25. Masubuchi N: Pharmacokinetics of DE-310, a novel macromolecular carrier system for the camptothecin analog DX-8951f, in tumor-bearing mice. Pharmazie 59: 374-377, 2004
26. Hsiang YH, Hertzberg R, Hecht S, Liu LF: Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J Biol Chem 260: 14873-14878, 1985
27. Mitsui I, Kumazawa E, Hirota Y, Aonuma M, Sugimori M, Ohsuki S, Uoto K, Ejima A, Terasawa H, Sato K: A new water-soluble camptothecin derivative, DX-8951f, exhibits potent antitumor activity against human tumors in vitro and in vivo. Jpn J Cancer Res 86: 776-782, 1995
28. Joto N, Ishii M, Minami M, Kuga H, Mitsui I, Tohgo A: DX-8951f, a water-soluble camptothecin analog, exhibits potent antitumor activity against a human lung cancer cell line and its SN-38-resistant variant. Int J Cancer 72: 680-686, 1997
29. Kumazawa E, Jimbo T, Ochi Y, Tohgo A: Potent and broad antitumor effects of DX-8951f, a water-soluble camptothecin derivative, against various human tumors xenografted in nude mice. Cancer Chemother Pharmacol 42: 210-220, 1998
30. Mitsui I, Kumazawa E, Hirota Y, Aonuma M, Sugimori M, Ohsuki S, Uoto K, Ejima A, Terasawa H, Sato K: A new water-soluble camptothecin derivative, DX-8951f, exhibits potent antitumor activity against human tumors in vitro and in vivo. Jpn J Cancer Res 86: 776-782, 1995
31. Nomoto T, Nishio K, Ishida T, Mori M, Saijo N: Characterization of a human small-cell lung cancer cell line resistant to a new water-soluble camptothecin derivative, DX-8951f. Jpn J Cancer Res 89: 1179-1186, 1998
32. Garrison MA, Hammond LA, Geyer CE, Jr., Schwartz G, Tolcher AW, Smetzer L, Figueroa JA, Ducharme M, Coyle J, Takimoto CH, De Jager RL, Rowinsky EK: A Phase I and pharmocokinetic study of exatecan mesylate administered as a protracted 21-day infusion in patients with advanced solid malignancies. Clin Cancer Res 9: 2527-2537, 2003
33. Minami H, Fujii H, Igarashi T, Itoh K, Tamanoi K, Oguma T, Sasaki Y: Phase I and pharmacological study of a new camptothecin derivative, exatecan mesylate (DX-8951f), infused over 30 minutes every three weeks. Clin Cancer Res 7: 3056-3064, 2001
34. Rowinsky EK, Johnson TR, Geyer CE, Jr., Hammond LA, Eckhardt SG, Drengler R, Smetzer L, Coyle J, Rizzo J, Schwartz G, Tolcher A, Von Hoff DD, De Jager RL: DX-8951f, a hexacyclic camptothecin analog, on a daily-times-five schedule: A phase I and pharmacokinetic study in patients with advanced solid malignancies. J Clin Oncol 18: 3151-3163, 2000
35. Sharma S, Kemeny N, Schwartz GK, Kelsen D, O'Reilly E, Ilson D, Coyle J, De Jager RL, Ducharme MP, Kleban S, Hollywood E, Saltz LB: Phase I study of topoisomerase I inhibitor exatecan mesylate (DX-8951f) given as weekly 24-hour infusions three of every four weeks. Clin Cancer Res 7: 3963-3970, 2001
36. Boige V, Raymond E, Faivre S, Gatineau M, Meely K, Mekhaldi S, Pautier P, Ducreux M, Rixe O, Armand JP: Phase I and pharmacokinetic study of the camptothecin analog DX-8951f administered as a 30-minute infusion every 3 weeks in patients with advanced cancer. J Clin Oncol 18: 3986-3992, 2000
37. Royce ME, Hoff PM, Dumas P, Lassere Y, Lee JJ, Coyle J, Ducharme MP, De Jager R, Pazdur R: Phase I and pharmacokinetic study of exatecan mesylate (DX-8951f): A novel camptothecin analog. J Clin Oncol 19: 1493-1500, 2001
38. Ringsdorf H: Structure and properties of pharmacologically active polymers. J Polym Sci Polym Symp 20: 135-153, 1975
39. Maeda H, Wu J, Sawa T, Matsumura Y, Hori K: Tumor vascular permeability and the EPR effect in macromolecular therapeutics: A review. J Control Release 65: 271-284, 2000
40. Kumazawa E, Ochi Y: DE-310, a novel macromolecular carrier system for the camptothecin analog DX-8951f: Potent antitumor activities in various murine tumor models. Cancer Sci 95: 168-175, 2004
41. Kumazawa E, Ochi Y: DE-310, a novel macromolecular carrier system for the camptothecin analog DX-8951f: Potent antitumor activities in various murine tumor models. Cancer Sci 95: 168-175, 2004
42. Soepenberg O, De Jonge A, Sparreboom A, de Bruijn P, Eskens F, De Heus G, Langman S, Cheverton P, Bastien L, Verweij J: Phase I and PK study of DE-310 given once every 2 or 6 wks (w) in pts with solid tumors. Proc Am Soc Clin Oncol 22: 131, 2003
43. Takimoto CH, Forero L, Schwartz GH, Tolcher AW, Hammond LA, Patnaik A, Ducharme M, Cooke B, De Jager R, Rowinsky EK: A phase I and pharmacokinetic study of DE-310 administered as a 3 hour infusion every 4 weeks (wks) to patients (pts) with advanced solid tumors or lymphomas. Proc Am Soc Clin Oncol 22: 130, 2003
44. Kumazawa E, Ochi Y: DE-310, a novel macromolecular carrier system for the camptothecin analog DX-8951f: Potent antitumor activities in various murine tumor models. Cancer Sci 95: 168-175, 2004