Interpatient variability in bioavailability of the intravenous formulation of topotecan given orally to children with recurrent solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 43, Issue 6, 1999, Pages 454-460

  Zamboni, William C ^a   Bowman, Laura C ^a   Tan, Ming ^a   Santana, Victor M ^a   Houghton, Peter J ^a,b   Meyer, William H ^a   Pratt, Charles B ^a   Heideman, Richard L ^a   Gajjar, Amar J ^a   Pappo, Alberto S ^a   Stewart, Clinton F ^a,b  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

Oral bioavailability; Pediatric solid tumors; Topotecan

Indexed keywords

TOPOTECAN;

ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; CHILD; CHILDHOOD CANCER; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; SOLID TUMOR; TREATMENT OUTCOME; TUMOR RECURRENCE;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; ANTINEOPLASTIC AGENTS; BIOLOGICAL AVAILABILITY; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; INJECTIONS, INTRAVENOUS; MALE; NEOPLASM RECURRENCE, LOCAL; NEOPLASMS; TOPOTECAN;

EID: 0032920492     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002800050923     Document Type: Article

References (35)

1. Takimoto CH, Wright J, Arbuck SG (1998) Clinical applications of the camptothecins. Biochimica et Biophysica 1400: 107
2. Stewart CF, Ratain MJ (1997) Topoisomerase interactive agents. In: Cancer: Principles and Practice of Oncology, edited by De Vita VT Jr, Hellman, Rosenberg SA. Lippincott-Raven, Philadelphia, PA, pp 452-467
3. Slichenmyer WJ, Rowinsky EK, Donehower RC, Kaufmann SH (1993) The current status of camptothecin analogues as antitumor agents. J Natl Cancer Inst 85: 271
4. Stewart CF, Zamboni WC, Crom WR, Gajjar AJ, Heideman RL, Furman WL, Meyer WH, Houghton PJ, Pratt CB (1996) Topoisomerase I interactive drugs in children with cancer. Invest New Drugs 14: 37
5. Schellens JHM, Creemers GJ, Beijnen JH, Rosing H, Boer-Dennert M de, McDonald M, Davies BE, Verweij J (1996) Bioavailability and pharmacokinetics of oral topotecan: a new topoisomerase I inhibitor. Br J Cancer 73: 1268
6. Creemers GJ, Gerrits CJH, Eckardt J, Schellens JH, Burris HA, Planting AS, Rodriguez GI, Loos WJ, Hudson I, Verweij J, Von Hoff DD (1997) Phase I and pharmacologic study of oral topotecan administered twice daily for 21 days to adult patients with solid tumors. J Clin Oncol 15: 1087
7. Giovanella BC, Stehlin JS, Wall ME, Wani MC, Nicholas AW, Liu LF, Silber R, Potmesil M (1989) DNA topoisomerase I-targeted chemotherapy of human colon cancer in xenografts. Science 246: 1046
8. Burris HA III, Hanauske AR, Johnson RK, Marshall MH, Kuhn JG, Hilsenbeck SG, Von Hoff DD (1992) Activity of topotecan, a new topoisomerase I inhibitor, against human tumor colony-forming units in vitro. J Natl Cancer Inst 84: 1816
9. Rowinsky EK, Grochow LB, Hendricks CB, Ettinger DS, Forastiere AA, Hurowitz LA, McGuire WP, Sartorius SE, Lubejko BG, Kaufmann SH, et al (1992) Phase I and pharmacologic study of topotecan: a novel topoisomerase I inhibitor. J Clin Oncol 10: 647
10. Houghton PJ, Chesire PJ, Myers L, Stewart CF, Synold TW, Houghton JA (1992) Evaluation of 9-dimethylaminomethyl-10-hydroxycamptothecin against xenografts derived from adult and childhood solid tumors. Cancer Chemother Pharmacol 31: 229
11. Hande KR, Krozely MG, Greco FA, Hainsworth JD, Johnson DH (1993) Bioavailability of low-dose oral etoposide. J Clin Oncol 11: 374
12. Zhou XJ, Zhou-Pan XR, Favre R, Rahmani R (1998) Relative bioavailability of two oral formulations of navelbine in cancer patients. Biopharm Drug Dispos 15: 577
13. Beijnen JH, Smith BR, Keijer WJ, Van Gijn R, Huinink WW, Vlasveld LT, Rodenhuis S, Underberg WJM (1990) High-performance liquid chromatographic analysis of the new antitumour drug SK & F 104864-A (NSC 609699) in plasma. J Pharm Biomed Anal 8: 789
14. Stewart CF, Baker SD, Heideman RL, Jones D, Crom WR, Pratt CB (1994) Clinical pharmacodynamics of continuous infusion topotecan in children: systemic exposure predicts hematologic toxicity. J Clin Oncol 12: 1946
15. Tubergen DC, Stewart CF, Pratt CB, Zamboni WC, Winick N, Santana VM, Dryer ZA, Kurtzberg J, Bell B, Grief H, Vietti TJ (1996) Phase I trial and pharmacokinetic (PK) and pharmacodynamics (PD) study of topotecan using a five-day course in children with refractory solid tumors: a Pediatric Oncology Group study. J Pediatr Hematol Oncol 18: 352
16. Baker SD, Heideman RL, Crom WR, Kuttesch JF, Gajjar A, Stewart CF (1996) Cerebrospinal pharmacokinetics and penetration of continuous infusion topotecan in children with central nervous system tumors. Cancer Chemother Pharmacol 37: 195
17. D'Argenio DZ, Schumitzky A (1990) ADAPT II user's guide. Biomedical Simulations Resource, University of Southern California, Los Angeles
18. Gibaldi M, Perrier D (1982) Pharmacokinetics. Marcel Dekker, New York
19. Neter J, Kutner MH, Nachtsheim CJ, Wasserman W (1995) Applied linear statistical models. Irwin, Chicago, Illinois
20. Anon (1996) The mixed procedure. SAS/stat changes and enhancements. SAS Institute, Cary, North Carolina
21. Creemers GJ, Schellens JH, Beijnen JH, Planting AS, Rosing H Boer-Dennert M de, Burg ME van der, Loos WJ, McDonald M, Stoter G, et al. (1994) Bioavailability of oral topotecan: a new topoisomerase I inhibitor (meeting abstract). Proc Am Soc Clin Oncol 13: A324
22. Kuhn JJ, Rizzo J, Eckardt J, Fields S, Cobb G, Rodriquez G, Rinadi D, Drengler R, Smith L, Peacock N, Thurman A, DeLaCruz P, Hodges S, Van Hoff D, Burris H (1995) Phase I bioavailability study of oral topotecan (meeting abstract). Proc Am Soc Clin Oncol 14: 474
23. Gerrits CJH, Burris H, Schellens JH, Eckardt JR, Planting AST, Burg ME van der, Rodriguez G, Loos WJ, Beurden V van, Hudson I, Fields S, Von Hoff DD, Verweij J (1998) Oral topotecan given once or twice daily for ten days: a phase I pharmacokinetic study in adult patients with solid tumors. Clin Cancer Res 4: 1153
24. Furman WL, Baker SD, Pratt CB, Rivera G, Evans WE, Stewart CF (1996) Escalating systemic exposure to topotecan following a 120-hr continuous infusion in children with relapsed acute leukemia. J Clin Oncol 14: 1504
25. Zamboni WC, Santana VM, Gajjar AJ, Meyer WH, Pappo AS, Houghton PJ, Stewart CF (1997) Pharmacokinetically guided dose adjustment reduces variability in topotecan (TPT) systemic exposure in children with solid tumors (meeting abstract). Proc Am Soc Clin Oncol 16: 205
26. Santana V, Zamboni WC, Gajjar A, Pappo AS, Houghton PJ, Meyer WH, Stewart C (1997) Pharmacokinetically guided use of topotecan (TPT) given (daily × 5) × 2, in children with solid tumors (meeting abstract). Proc Am Soc Clin Oncol 16: 511
27. Evans WE, Rodman JH, Relling MV, Crom WR, Rivera GK, Pratt CB (1991) Concept of maximum tolerated systemic exposure and its application to phase I-II studies of anticancer drugs. Med Pediatr Oncol 19: 153
28. Evans WE, Relling MV (1989) Clinical pharmacokinetics-pharmacodynamics of anticancer drugs. Clin Pharmacokinet 16: 327
29. Tubergen D, Pratt C, Stewart C, Vietti T (1994) Phase I study of topotecan in children with refractory solid tumors: a Pediatric Oncology Group study (meeting abstract). Proc Am Soc Clin Oncol. 13: A463
30. Rodman JH, Relling MV, Stewart CF, Synold TW, McLeod H, Kearns C, Stute N, Crom WR, Evans WE (1993) Clinical pharmacokinetics and pharmacodynamics of anticancer drugs in children. Semin Oncol 20: 18
31. Pommier Y, Leteurtre F, Fesen MR, Fujimori A, Bertrand R, Solary E, Kohlhagen G, Kohn KW (1994) Cellular determinants of sensitivity and resistance to DNA topoisomerase inhibitors. Cancer Invest 12: 530
32. Tanizawa A, Fujimori A, Fujimori Y, Pommier Y (1994) Comparison of topoisomerase I inhibition, DNA damage, and cytotoxicity of camptothecin derivatives presently in clinical trials. J Natl Cancer Inst 86: 836
33. Slichenmyer WJ, Donehower RC, Chen TL, Bowling MK, McGuire WP, Rowinsky EK (1995) Pretreatment H2 receptor antagonists that differ in P450 modulation activity: comparative effects on paclitaxel clearance rates and neutropenia. Cancer Chemother Pharmacol 36: 227
34. Zamboni WC, Heideman RL, Meyer WH, Gajjar AJ, Crom WR, Stewart CF (1996) Pharmacokinetics (PK) of topotecan in pediatric patients with normal and altered renal function (meeting abstract). Proc Am Soc Clin Oncol 15: 371
35. Pommier Y (1993) DNA topoisomerase I and II in cancer chemotherapy: update and perspectives. Cancer Chemother Pharmacol 32: 103