Pharmacokinetic studies of 9-nitrocamptothecin on intermittent and continuous schedules of administration in patients with solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 54, Issue 6, 2004, Pages 487-496

  Jung, Laura L ^a   Ramanathan, Ramesh K ^a,b   Egorin, Merrill J ^a,b   Jin, Ruzhi ^a   Belani, Chandra P ^a,b   Potter, Douglas M ^a,c   Strychor, Sandra ^a   Trump, Donald L ^a,b   Walko, Christine ^a   Fakih, Marwan ^a,b   Zamboni, William C ^a,b,d  

^a UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^d UNIVERSITY OF PITTSBURGH   (United States)

Author keywords

9 Aminocamptothecin; 9 Nitrocamptothecin; Oral administration; Pharmacokinetics

Indexed keywords

ANTINEOPLASTIC AGENT; DRUG METABOLITE; RUBITECAN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG METABOLISM; DRUG URINE LEVEL; HEMOCONCENTRATION; HUMAN; MATHEMATICAL COMPUTING; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; STATISTICAL SIGNIFICANCE;

ADMINISTRATION, ORAL; CAMPTOTHECIN; DRUG ADMINISTRATION SCHEDULE; HUMANS; NEOPLASMS;

EID: 19944367255     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-004-0835-9     Document Type: Article

References (35)

1. Hsiang YH, Hertzberg R, Hecht S, Liu LF (1985) Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J Biol Chem 260:14873
2. Covey JM, Jaxel C, Kohn KW, Pommier Y (1989) Protein-linked DNA strand breaks induced in mammalian cells by camptothecin, an inhibitor of topoisomerase I. Cancer Res 49:5016
3. Jaxel C, Kohn KW, Wani MC, Wall ME, Pommier Y (1989) Structure-activity study of the actions of camptothecin derivatives on mammalian topoisomerase I: evidence for a specific receptor site and a relation to antitumor activity. Cancer Res 49:1465
4. Kirstein MN, Houghton PJ, Cheshire PJ, Richmond LB, Smith AK, Hanna SK, Stewart CF (2001) Relation between 9-aminocamptothecin systemic exposure and tumor response in human solid tumor xenografts. Clin Cancer Res 7:358
5. Pazdur R, Diaz-Canton E, Ballard WP, Bradof JE, Graham S, Arbuck SG, Abbruzzese JL, Winn R (1997) Phase II trial of 9-aminocamptothecin administered as a 72-hour continuous infusion in metastatic colorectal carcinoma. J Clin Oncol 15:2905
6. Takimoto CH, Thomas R (2000) The clinical development of 9-aminocamptothecin. Ann N Y Acad Sci 922:224
7. Furman WL, Stewart CF, Poquette CA, Pratt CB, Santana VM, Zamboni WC, Bowman LC, Ma MK, Hoffer FA, Meyer WH, Pappo AS, Walter AW, Houghton PJ (1999) Direct translation of a protracted irinotecan schedule from a xenograft model to a phase I trial in children. J Clin Oncol 17:1815
8. Thompson J, Zamboni WC, Cheshire PJ, Lutz L, Luo X, Li Y, Houghton JA, Stewart CF, Houghton PJ (1997) Efficacy of systemic administration of irinotecan against neuroblastoma xenografts. Clin Cancer Res 3:423
9. Hsiang YH, Lihou MG, Liu LF (1989) Arrest of replication forks by drug-stabilized topoisomerase I-DNA cleavable complexes as a mechanism of cell killing by camptothecin. Cancer Res 49:5077
10. Del Bino G, Darzynkiewicz Z (1991) Camptothecin, teniposide, or 4′-(9-acridinylamino)-3-methanesulfon-m-anisidide, but not mitoxantrone or doxorubicin, induces degradation of nuclear DNA in the S phase of HL-60 cells. Cancer Res 51:1165
11. Houghton PJ, Cheshire PJ, Hallman JD, Lutz L, Friedman HS, Danks MK, Houghton JA (1995) Efficacy of topoisomerase I inhibitors, topotecan and irinotecan, administered at low dose levels in protracted schedules to mice bearing xenografts of human tumors. Cancer Chemother Pharmacol 36:393
12. Zamboni WC, Bowman LC, Tan M, Santana VM, Houghton PJ, Meyer WH, Pratt CB, Heideman RL, Gajjar AJ, Pappo AS, Stewart CF (1999) Interpatient variability in bioavailability of the intravenous formulation of topotecan given orally to children with recurrent solid tumors. Cancer Chemother Pharmacol 43:454
13. Gupta E, Luo F, Lallo A, Ramanathan S, Vyas V, Rubin E, Sinko P (2000) The intestinal absorption of camptothecin, a highly lipophilic drug, across Caco-2 cells is mediated by active transporter(s). Anticancer Res 20:1013
14. 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 (1999) 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
15. Loos WJ, Gelderblom H, Sparreboom A, Verweij J, de Jonge MJ (2000) Inter- and intrapatient variability in oral topotecan pharmacokinetics: implications for body-surface area dosage regimens. Clin Cancer Res 6:2685
16. Kruijtzer CM, Beijnen JH, Rosing H, Bokkel Huinink WW, Schot M, Jewell RC, Paul EM, Schellens JH (2002) Increased oral bioavailability of topotecan in combination with the breast cancer resistance protein and P-glycoprotein inhibitor GF120918. J Clin Oncol 20:2943
17. Akhtar S, Beckman RA, Mould DR, Doyle E, Fields SZ, Wright J (2000) Pretreatment with ranitidine does not reduce the bioavailability of orally administered topotecan. Cancer Chemother Pharmacol 46:204
18. Mi Z, Burke TG (1994) Differential interactions of camptothecin lactone and carboxylate forms with human blood components. Biochemistry 33:10325
19. Mi Z, Burke TG (1994) Marked interspecies variations concerning the interactions of camptothecin with serum albumins: a frequency-domain fluorescence spectroscopic study. Biochemistry 33:12540
20. Schrijvers D, Highley M, De Bruyn E, Van Oosterom AT, Vermorken JB (1999) Role of red blood cells in pharmacokinetics of chemotherapeutic agents. Anticancer Drugs 10:147
21. Schoemaker NE, Mathot RAA, Schoffski P, Rosing H, Schellens JHM, Beijnen JH (2002) Development of an optimal pharmacokinetic sampling schedule for rubitecan administered orally in a daily times five schedule. Cancer Chemother Pharmacol 50:514-517
22. Raymond D, Campone M, Stupp R, Menten J, Chollet P, Lesimple T, Fety-Deporte R, Lacombe D, Paoletti X, Fumoleau P (2002) Multicentre phase II and pharmacokinetic study of RFS2000 (9-nitrocamptothecin) administered orally 5 days a week in patients with glioblastoma multiforme. Eur J Cancer 38:1348-1350
23. Schoffski P, Herr A, Vermerken JB, Van den BJ, Beijnen JH, Rosing H, Volk J, Ganser A, Adank S, Botma HJ, Wanders J (2002) Clinical phase II study and pharmacological evaluation of rubitecan in non-pretreated patients with metastatic colorectal cancer - significant effect of food intake on the bioavailability of the oral camptothecin analogue. Eur J Cancer 38:807
24. Natelson EA, Giovanella BC, Verschraegen CF, Fehir KM, De Ipolyi PD, Harris N, Stehlin JS (1996) Phase I clinical and pharmacological studies of 20-(S)-camptothecin and 20-(5)-9-nitrocamptothecin as anticancer agents. Ann N Y Acad Sci 803:224
25. Zamboni WC, Jung LL, Egorin MJ, Potter DM, Friedland DM, Belani CP, Agarwala SS, Wong MM, Fakih M, Trump DL, Jin R, Strychor S, Vozniak M, Troetschel M, Ramanathan RK (2004) Phase I and pharmacologic study of intermittently administered 9-nitrocamptothecin in patients with advanced solid tumors. Clin Cancer Res 10:5058
26. Potter DM (2002) Adaptive dose finding for phase I clinical trials of drugs used for chemotherapy of cancer. Stat Med 21:1805
27. O'Quigley J, Pepe M, Fisher L (1990) Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 46:33
28. Supko JG, Malspeis L (1992) Liquid chromatographic analysis of 9-aminocamptothecin in plasma monitored by fluorescence induced upon post-column acidification. J Liquid Chromatogr 15:3261
29. D'Argenio DZ, Schmuitzky A (1997) ADAPT II user's guide. Biomedical Simulation Resource, University of Southern California, Los Angeles
30. Rowland M, Tozer T (eds) (1999) Clinical pharmacokinetics: concepts and applications. Lea and Febiger, Philadelphia
31. Verschraegen CF, Gilbert BE, Huaringa AJ, Newman R, Harris N, Leyva FJ, Keus L, Campbell K, Nelson-Taylor T, Knight V (2000) Feasibility, phase I, and pharmacological study of aerosolized liposomal 9-nitro-20(S)-camptothecin in patients with advanced malignancies in the lungs. Ann N Y Acad Sci 922:352
32. Gilbert BE, Newman R, Zamboni WC, Knight V, Verschraegen CF (2001) Pharmacokinetics of multiple 9-nitro-camptothecin (9NC) liposome aerosols during a Phase I study: levels of total and lactone forms, and its conversion to 9-amino-cam-ptothecin (9AC). Proc Am Soc Clin One 20:90b
33. Gounder M, Saleem A, Roychowdhury M (2002) Metabolism of 9-nitrocamptothecin (RFS2000/9NC) to 9-aminocamptothecin (9AC) in patients and in vitro. Proc Am Assoc Cancer Res 42
34. Pantazis P, Harris N, Mendoza J, Giovanella B (1995) The role of pH and serum albumin in the metabolic conversion of 9-nitrocamptothecin to 9-aminocamptothecin by human hematopoietic and other cells. Eur J Haematol 55:211
35. Hinz HR, Harris NJ, Natelson EA, Giovanella BC (1994) Pharmacokinetics of the in vivo and in vitro conversion of 9-nitro-20(5)-camptothecin to 9-amino-20(5)-camptothecin in humans, dogs, and mice. Cancer Res 54:3096