Pharmacokinetics and pharmacodynamics of topotecan given on a daily-times-five schedule in phase II clinical trials using a limited-sampling procedure

Cancer Chemotherapy and Pharmacology

Volumn 38, Issue 3, 1996, Pages 254-260

  Van Warmerdam, Laurence J C ^a,b   Creemers, Geert Jan ^c   Rodenhuis, Sjoerd ^a   Rosing, Hilde ^b   De Boer Dennert, Maureen ^c   Schellens, Jan H M ^c   Ten Bokkel Huinink, Wim W ^a   Davies, Brian E ^e   Maes, Robert A A ^d   Verweij, Jaap ^c   Beijnen, Jos H ^a,b,d  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b SLOTERVAART HOSPITAL   (Netherlands)

^c ERASMUS MC CANCER INSTITUTE   (Netherlands)

^d UTRECHT UNIVERSITY   (Netherlands)

^e GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Limited sampling model; Pharmacodynamics; Pharmacokinetics; Phase II; Topotecan

Indexed keywords

CAMPTOTHECIN DERIVATIVE; DNA TOPOISOMERASE INHIBITOR; TOPOTECAN;

ADULT; AGED; ALOPECIA; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CONFORMATION; DRUG MONITORING; FEMALE; GRANULOCYTOPENIA; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; MODEL; PHASE 2 CLINICAL TRIAL; PREDICTION; PRIORITY JOURNAL; SAMPLING; SOLID TUMOR; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

AGED; AGRANULOCYTOSIS; ANTINEOPLASTIC AGENTS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DNA TOPOISOMERASES, TYPE I; DOSE-RESPONSE RELATIONSHIP, DRUG; FEASIBILITY STUDIES; FEMALE; HUMANS; INFUSION PUMPS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; OVARIAN NEOPLASMS; THROMBOCYTOPENIA; TOPOTECAN;

EID: 0029890912     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002800050479     Document Type: Article

References (26)

1. Anonymous (1988) DNA topoisomerases - new twists to tumour therapy. Lancet I:512
2. Beijnen JH, Smith BR, Keijer WJ, Van Gijn R, Ten Bokkel 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
3. Gottlieb JA, Guarino AM, Call JB, Oliverio VT, Block JB ( 1970) Preliminary pharmacologic and clinical evaluation of camptothecin sodium (NSC 100880). Cancer Chemother Rep 54:461
4. Grochow LB, Rowinsky EK, Johnson R, Ludeman S, Kaufmann SH, McCabe FL, Smith BR, Hurowitz L, DeLisa A, Donehower RC, Noe D (1992) Pharmacokinetics and pharmacodynamics of topotecan in patients with advanced cancer. Drug Metab Dispos 20:706
5. Haas NB, LaCreta FP, Walczak J, Hudes GR, Brennan JM, Ozols RF, O'Dwyer PJ (1994) Phase I/pharmacokinetic study of topotecan by 24-hour continuous infusion weekly. Cancer Res 54:1220
6. Hertzberg RP, Caranfa MJ, Hecht SM (1989) On the mechanism of topoisomerase I inhibition by camptothecin: evidence for binding to an enzyme-DNA complex. Biochemistry 32:715
7. Hertzberg RP, Caranfa MJ, Holden KG, Jakas DR, Gallagher G, Mattern MR, Mong SM, Bartus JO, Johnson RK, Kingsbury WD (1989) Modification of the hydroxy lactone ring of camptothecin : inhibition of mammalian topoisomerase I and biological activity. J Med Chem 32:715
8. 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
9. Kantarjian HM, Beran M, Ellis A, Zwelling L, O'Brien S, Cazenave L, Koller C, Rios MB, Plunkett W, Keating M, Estey EH (1993) Phase I study of topotecan, a new topoisomerase I inhibitor, in patients with refractory or relapsed acute leukemia. Blood 81:1146
10. Law TM, Ilson DH, Motzer RJ (1994) Phase II trial of topotecan in patients with advanced renal cell carcinoma. Invest New Drugs 12:143
11. Lynch TJ, Kalish L, Strauss G, Elias A, Skarin A, Shulman LN, Posner M, Frei E (1994) Phase II trial of topotecan in metastatic non-small cell lung cancer. J Clin Oncol 12:347
12. Moertel CG, Schutt AJ, Reitemeier RJ, Hahn RG (1972) Phase II study of camptothecin in the treatment of advanced gastrointestinal cancer. Cancer Chemother Rep 56:95
13. Muggia FM, Creaven PJ, Hansen H, Cohen MH, Selawry OS (1972) Phase I clinical trial of weekly and daily treatment with camptothecin:correlation with preclinical studies. Cancer Chemother Rep 56:515
14. Newell DR (1994) Pharmacokinetic monitoring of novel topoisomerase I inhibitors and tubulin binding agents in phase II clinical trials. Ann Oncol 5:164
15. Rowinsky EK, Grochow LB, Hendriks CB, Ettinger DS, Forastiere AA, Hurowitz LA, McGuire WP, Sartorius SE, Lubejko BG, Kaufmann SH, Donehower RC (1992) Phase I and pharmacologic study of topotecan: a novel topoisomerase I inhibitor. J Clin Oncol 10:647
16. Saltz L, Sirott M, Young C, Tong W, Niedzwiecki D, Tzy-Jyun Y, Tao Y, Trochanowski B, Wright P, Barbosa K, Toomasi F, Kelsen D (1993) Phase I clinical and pharmacology study of topotecan given daily for 5 consecutive days to patients with advanced solid tumors, with attempt at dose intensification using recombinant granulocyte colony-stimulating factor. J Natl Cancer Inst 18:1499
17. Sheiner LB, Beal SL (1981) Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 9:503
18. Sirott MN, Saltz L, Young C, Tong W, Trochanowski B, Niedzwiecki D, Toomasi F, Kelsen D (1991) Phase I and clinical pharmacologic study of intravenous topotecan. Proc Am Assoc Clin Oncol 10:104
19. Slichenmyer WJ, Rowinsky EK, Donehower RC, Kaufmann SH (1993) The current status of camptothecin analogues as anti-tumor agents. J Natl Cancer Inst 85:271
20. Steward 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 9:1946
21. Underberg WJM, Goossen RMJ, Smith BR, Beijnen JH (1990) Equilibrium kinetics of the new experimental anti-tumour compound SK&F 104864-A in aqueous solution. J Pharm Biomed Anal 8:681
22. Van Warmerdam LJC, Verweij J, Rosing H, Schellens JHM, Maes RAA, Beijnen JH (1994) Limited sampling models for topotecan pharmacokinetics. Ann Oncol 5:259
23. Van Warmerdam LJC, Verweij J, Schellens JHM, Rosing H, Davies BE, De Boer-Dennert M, Maes RAA, Beijnen JH (1995) Pharmacokinetics and pharmacodynamics of topotecan administered in a daily times five regimen every three weeks. Cancer Chemother Pharmacol 35:237-245
24. Verweij J, Lund B, Beijnen J, Planting A, Boer-Dennert M de, Koier I, Rosing H, Hansen H (1993) Phase I and pharmacokinetic study of topotecan, a new topoisomerasc I inhibitor. Ann Oncol 4:673
25. Wall JG, Burris HA, Von Hoff DD, Rodriguez G, Kneuper-Hall R, Shaffer D, O'Rourke T, Brown T, Weiss G, Clark G, McVea S. Brown J, Johbson R, Friedman C, Smith B, Mann WS, Kuhn J (1992) A phase I clinical and pharmacokinetic study of the topoisomerase I inhibitor topotecan (SK&F 104864) given as an intravenous bolus every 21 days. Anticancer Drugs 3:337
26. Wall ME, Wani MC (1977) Antineoplastic agents from plants. Annu Rev Pharmacol Toxicol 17:117