Phase I and pharmacodynamic study of the topoisomerase I-inhibitor topotecan in patients with refractory acute leukemia

Journal of Clinical Oncology

Volumn 12, Issue 10, 1994, Pages 2193-2203

  Rowinsky, Eric K ^a   Adjei, Alex ^b   Donehower, Ross C ^b   Gore, Steven D ^b   Jones, Richard J ^b   Burke, Philip J ^b   Cheng, Yung Chi ^b   Grochow, Louise B ^b   Kaufmann, Scott H ^b  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

DAUNORUBICIN; DNA TOPOISOMERASE; GLYCOPROTEIN P; ISOMERASE INHIBITOR; QUINIDINE; TOPOTECAN;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LEUKEMIA; ALOPECIA; ANTINEOPLASTIC ACTIVITY; ANUS; ARTICLE; BONE MARROW SUPPRESSION; CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG ERUPTION; DRUG MECHANISM; DYSPHAGIA; HUMAN; IMMUNOBLOTTING; IMMUNOHISTOCHEMISTRY; INTRAVENOUS DRUG ADMINISTRATION; MUCOSA INFLAMMATION; OROPHARYNX; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; VOMITING;

EID: 0028090410     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1994.12.10.2193     Document Type: Article

References (47)

1. Slichenmyer WJ, Rowinsky EK, Donehower RC, et al: The current status of camptothecin analogues as antitumor agents. J Natl Cancer Inst 85:271-291, 1993
2. Potmesil M: Camptothecins: From bench research to hospital wards. Cancer Res 54:1431-1439, 1994
3. Hsiang Y-H, Hertzberg R, Hecht S, et al: Camptothecin induces protein-linked DNA breaks via mamalian DNA topoisomerase I. J Biol Chem 260:14873-14878, 1987
4. Hsiang Y-H, Liu LF: Identification of mamalian DNA topoisomerase I as an intracellular target of the anticancer drug camptothecin. Cancer Res 48:1722-1726, 1988
5. Eng W-K, Faucette L, Johnson RK, et al: Evidence that DNA topoisomerase I is necessary for the cytotoxic effects of camptothecin. Mol Pharmacol 34:755-760, 1988
6. Jaxel C, Kohn KW, Wani MC, et al: 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 49:1465-1469, 1989
7. Liu LF: DNA topoisomerase poisons as antitumor agents. Annu Rev Biochem 58:351-375, 1989
8. Tsao Y-P, Russo A, Nyamuswa G, et al: Interaction between replication forks and topoisomerase I-DNA cleavable complexes: Studies in a cell-free SV-40 DNA replication system. Cancer Res 5:5908-5914, 1993
9. Johnson RK, Hertzberg RP, Kingsbury WD, et al: Preclinical profile of SK&F 104864, a water soluble analogue of camptothecin. Proceedings of the Sixth NCI-EORTC Symposium on New Drugs in Cancer Therapy, Kluwer Academic, Amsterdam, the Netherlands, 1989, p 301 (abstr)
10. Kingsbury WD, Boehm JC, Jakas DR, et al: Synthesis of water-soluble (aminoalkyl) camptothecin analogues: Inhibition of topoisomerase I and antitumor activity. J Med Chem 34:98-107, 1991
11. Hendricks CB, Rowinsky EK, Grochow LB, et al: Effect of p-glycoprotein expression on accumulation and cytotoxicity of topotecan (SK&F 104864), a new camptothecin analog. Cancer Res 52:2268-2278, 1992
12. Chen AY, Yu C, Potmesil M, Wall ME, et al: Camptothecin overcomes mdr1-mediated resistance in human KB carcinoma cells. Cancer Res 51:6039-6044, 1991
13. Rowinsky E, Grochow L, Hendricks C, et al: Phase I and pharmacologic study of topotecan: A novel topoisomerase I inhibitor. J Clin Oncol 10:647-656, 1992
14. Burns HA, Kuhn J, Wall J, et al: Early clinical trials of topotecan, a new topoisomerase I inhibitor. Proceedings of the Seventh NCI-EORTC Symposium on New Drugs in Cancer Therapy, Kluwer Academic, Amsterdam, the Netherlands, 1992, p 118 (abstr)
15. Bennet JM, Catovski D, Daniel MT, et al: Proposals for the classifications of the acute leukemias. Br J Hematol 33:451-455, 1976
16. Bennet JM, Catovski D, Daniel MT, et al: The morphological classification of acute lymphoblastic leukemia: Concordance among observers and clinical correlations. Am J Hematol 47:553-561, 1981
17. Kantajarian HM, Beran M, Ellis A, et al: Phase I study of topotecan, a new topoisomerase I inhibitor, in patients with refractory or relapsed leukemia. Blood 81:1146-1151, 1993
18. Grochow LB, Rowinsky EK, Johnson R, et al: Pharmacokinetics and pharmacodynamics of topotecan. Drug Metab Dispos 20:706-712, 1992
19. Guidelines for Reporting of Adverse Drug Reactions. Bethesda, MD, Division of Cancer Treatment, National Cancer Institute, 1988
20. Cheson BD, Cassileth PA, Head DR, et al: Report on the National Cancer Institute - sponsored workshop on definitions of diagnosis and response in acute myeloid leukemia. J Clin Oncol 8:813-819, 1990
21. Kaufmann SH, McLaughlin SJ, Kastan MB, et al: Topoisomerase II levels during granulocytic maturation in vitro and in vivo. Cancer Res 51:3534-3543, 1994
22. Kaufmann SH, Karp JE, Jones RJ, et al: Topoisomerase II levels and drug sensitivity in adult acute myelogenous leukemia. Blood 83:517-530, 1994
23. Jones RJ, Miller CB, Zehnbauer BA, et al: In vitro evaluation of combination drug purging for autologous bone marrow transplantation. Bone Marrow Transplant 5:301-309, 1990
24. Kaufmann SH: Additional members of the rat liver lamin polypeptide family. J Biol Chem 264:13946-13955, 1989
25. Chang JY, Dethlefsen LA, Barley LR, et al: Characterization of camptothecin-resistant Chinese hamster lung cells. Biochem Pharmacol 43:2443-2452, 1992
26. Geller RB, Burke PJ, Karp JE, et al: A two-step timed sequential treatment for acute myelocytic leukemia. Blood 74:1499-1508, 1989
27. Mattem MR, Hofmann GA, Polsky RM, et al: Cross resistance of mdr, p-glycoprotein overexpressing CHO cells to camptothecin analogues. Proc Am Assoc Cancer Res 34:424, 1993 (abstr)
28. Muller MT, Pfund WP, Mehta VB, et al: Eukaryotic type I topoisomerase is enriched in the nucleolus and catalytically active on ribosomal DNA. EMBO J 4:1237-1243, 1985
29. Negoro S, Fukuoka M, Masuda N, et al: Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small cell lung cancer. J Natl Cancer Inst 83:1164-1168, 1991
30. Ohe Y, Saski Y, Shinkai T, et al: Phase I and pharmacokinetic study of CPT-11 with 5-day continuous infusion. J Natl Cancer Inst 12:972-974, 1992
31. Rothenberg ML, Kuhn J, Burris HA, et al: A phase I and pharmacokinetic trial of CPT-11 in patients with refractory solid tumors. J Clin Oncol 11:2194-2204, 1993
32. Rowinsky EK, Grochow LB, Ettinger DS, et al: Phase I and pharmacologic study of the novel topoisomerase I inhibitor CPT-11 administered as a 90 minute infusion every 3 weeks. Cancer Res 54:427-436, 1994
33. Gandia D, Abigerges D, Armand JP, et al: CPT-11-Induced cholinergic effects in cancer patients. J Clin Oncol 11:196-197, 1993 (letter)
34. Giovanella BC, Stehlin JS, Wall ME, et al: DNA-topoisomerase I-targeted chemotherapy of human colon cancer in xenografts. Science 246:1046-1048, 1989
35. Husain I, Mohler JL, Seigler HF, et al: Elevation of topoisomerase I messenger RNA, protein, and catalytic activity in human tumors: Demonstration of tumor-type specificity and implications for cancer chemotherapy. Cancer Res 54:539-546, 1994
36. Hwong C-L, Chen C-Y, Shang H-F: Increased synthesis and degradation of DNA topoisomerase I during the initial phase of human T lymphocyte proliferation. J Biol Chem 268:18982-18986, 1993
37. Hsiang Y-H, Wu H-Y, Liu LF: Proliferation-dependent regulation of DNA topoisomerase II in cultured human cells. Cancer Res 48:3230-3235, 1988
38. Champoux JJ, Young LS, Been MD: Studies on the regulation and specificity of DNA untwisting enzyme. Cold Spring Harbor Symp Quant Biol 43:53-58, 1979
39. Katz EJ, Vick JS, Kling KM, et al: Effects of topoisomerase modulators on cisplatin cytotoxicity in human ovarian carcinoma cell. Eur J Cancer 26:724-727, 1990
40. Kano Y, Suzuki K, Akutsu M, et al: Effects of CPT-11 in combination with other anticancer agents in culture. Int J Cancer 50:604-610, 1992
41. Johnson R, McCabe F, Yu Y: Combination regimens with topotecan in animal tumor models. Proceedings of the Seventh NCI-EORTC Symposium on New Drugs in Cancer Therapy, Kluwer Academic, Amsterdam, the Netherlands, 1992, p 85 (abstr)
42. Rowinsky E, Grochow L, Kaufmann S, et al: Sequence-dependent effects of topotecan and cisplatin in a phase I and pharmacokinetic study. Proc Am Soc Clin Oncol 13:142, 1994 (abstr 36)
43. Masuda N, Fukuoka M, Takada M, et al: CPT-11 in combination with cisplatin for non-small cell lung cancer. J Clin Oncol 10:1775-1780, 1992
44. Kaufmann SH: Antagonism between camptothecin and topoisomerase II-directed chemotherapeutic agents in a human leukemia cell line. Cancer Res 49:1129-1136, 1991
45. Bertrand R, O'Connor P, Kerrigan D, et al: Sequential administration of camptothecin and etoposide circumvents the antagonistic cytotoxicity of simultaneous drug administration in slowly growing human colon-carcinoma HT-29 cells. Eur J Cancer 28A:743-748, 1992
46. Anzai H, Frost P, Abbruzzese JL: Synergistic cytotoxicity with combined inhibition of topoisomerase I and II. Proc Am Assoc Cancer Res 33:431, 1992 (abstr)
47. Anzai H, Frost P, Abbruzzese JL: Synergistic cytotoxicity with 2′-deoxy-5-aza-cytidine and topotecan in vitro and in vivo. Cancer Res 52:2180-2185, 1992