Randomized phase I/II study of troxacitabine combined with cytarabine, idarubicin, or topotecan in patients with refractory myeloid leukemias

Journal of Clinical Oncology

Volumn 21, Issue 6, 2003, Pages 1050-1056

  Giles, Francis J ^a   Faderl, Stefan ^a   Thomas, Deborah A ^a   Cortes, Jorge E ^a   Garcia Manero, Guillermo ^a   Douer, Dan ^a   Levine, Alexandra M ^a   Koller, Charles A ^a   Jeha, Sima S ^a   O'Brien, Susan M ^a   Estey, Elihu H ^a   Kantarjian, Hagop M ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTARABINE; IDARUBICIN; TOPOTECAN; TROXACITABINE; 1,3 DIOXOLANE DERIVATIVE; ANTINEOPLASTIC AGENT; CYTOSINE; DRUG DERIVATIVE;

ACUTE GRANULOCYTIC LEUKEMIA; ARTICLE; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG ERUPTION; HAND FOOT SYNDROME; HUMAN; HYPERBILIRUBINEMIA; LIVER DISEAASE; LIVER DISEASE; LIVER TRANSAMINITIS; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MYELODYSPLASTIC SYNDROME; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; ADOLESCENT; ADULT; AGED; CHILD; DRUG ADMINISTRATION; FEMALE; MALE; MIDDLE AGED; MYELOID LEUKEMIA; PRESCHOOL CHILD;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHILD; CHILD, PRESCHOOL; CYTARABINE; CYTOSINE; DIOXOLANES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; IDARUBICIN; LEUKEMIA, MYELOCYTIC, ACUTE; LEUKEMIA, MYELOID; LEUKEMIA, MYELOID, CHRONIC; MALE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; TOPOTECAN; TREATMENT OUTCOME;

EID: 0037445119     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.04.023     Document Type: Article

References (39)

1. Mansour TS, Jin H, Wang W, et al: Anti-human immunodeficiency virus and anti-hepatitis-B virus activities and toxicities of the enantiomers of 2′-deoxy-3′-oxa-4′-thiocytidine and their 5-fluoro analogues in vitro. J Med Chem 38:1-4, 1995
2. Balzarini J, Wedgwood O, Kruining J, et al: Anti-HIV and anti-HBV activity and resistance profile of 2′, 3′-dideoxy-3′- thiacytidine (3TC) and its arylphosphoramidate derivative CF 1109. Biochem Biophys Res Commun 225:363-369, 1996
3. Mar EC, Chu CK, Lin JC: Some nucleoside analogs with anti-human immunodeficiency virus activity inhibit replication of Epstein-Barr virus. Antiviral Res 28:1-11, 1995
4. Coates JA, Cammack N, Jenkinson HJ, et al: (-)-2′-deoxy-3′- thiacytidine is a potent, highly selective inhibitor of human immunodeficiency virus type 1 and type 2 replication in vitro. Antimicrob Agents Chemother 36:733-739, 1992
5. Grove KL, Cheng YC: Uptake and metabolism of the new anticancer compound beta-L-(-)- dioxolane-cytidine in human prostate carcinoma DU-145 cells. Cancer Res 56:4187-4191, 1996
6. Giles FJ, Cortes JE, Baker SD, et al: Troxacitabine, a novel dioxolane nucleoside analog, has activity in patients with advanced leukemia. J Clin Oncol 19:762-771, 2001
7. Giles FJ, Garcia-Manero G, Cortes JE, et al: Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with refractory leukemia. J Clin Oncol 20:656-664, 2002
8. Estey EH, Thall PF, Cortes JE, et al: Comparison of idarubicin + ara-C-, fludarabine + ara-C-, and topotecan + ara-C-based regimens in treatment of newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts in transformation, or refractory anemia with excess blasts. Blood 98:3575-3583, 2001
9. Beran M, Estey E, O'Brien S, et al: Topotecan and cytarabine is an active combination regimen in myelodysplastic syndromes and chronic myelomonocytic leukemia. J Clin Oncol 17:2819-2830, 1999
10. Beran M, Kantarjian H: Results of topotecan-based combination therapy in patients with myelodysplastic syndromes and chronic myelomonocytic leukemia. Semin Hematol 36:3-10, 1999
11. Lee ST, Jang JH, Suh HC, et al: Idarubicin, cytarabine, and topotecan in patients with refractory or relapsed acute myelogenous leukemia and high-risk myelodysplastic syndrome. Am J Hematol 68:237-245, 2001
12. Beran M, Estey E, O'Brien SM, et al: Results of topotecan single-agent therapy in patients with myelodysplastic syndromes and chronic myelomonocytic leukemia. Leuk Lymphoma 31:521-531, 1998
13. Beran M, Shen Y, Kantarjian H, et al: High-dose chemotherapy in high-risk myelodysplastic syndrome: Covariate-adjusted comparison of five regimens. Cancer 92:1999-2015, 2001
14. Estey E, Kornblau S, Pierce S, et al: A stratification system for evaluating and selecting therapies in patients with relapsed or primary refractory acute myelogenous leukemia. Blood 88:756, 1996
15. Kantarjian HM, Cortes J, O'Brien S, et al: Imatinib mesylate (STI571) therapy for Philadelphia chromosome-positive chronic myelogenous leukemia in blast phase. Blood 99:3547-3553, 2002
16. Grove KL, Guo X, Liu SH, et al: Anticancer activity of beta-L-dioxolane-cytidine, a novel nucleoside analogue with the unnatural L configuration. Cancer Res 55:3008-3011, 1995
17. Kadhim SA, Bowlin TL, Waud WR, et al: Potent antitumor activity of a novel nucleoside analogue, BCH-4556 (beta-L-dioxolane-cytidine), in human renal cell carcinoma xenograft tumor models. Cancer Res 57:4803-4810, 1997
18. Kukhanova M, Liu SH, Mozzherin D, et al: L- and D-enantiomers of 2′, 3′-dideoxycytidine 5′-triphosphate analogs as substrates for human DNA polymerases. Implications for the mechanism of toxicity. J Biol Chem 270:23055-23059, 1995
19. Chou KM, Kukhanova M, Cheng YC: A novel action of human apurinic/apyrimidinic endonuclease: Excision of L-configuration deoxyribo-nucleoside analogs from the 3′ termini of DNA. J Biol Chem 275:31009-31015, 2000
20. Chiba P, Tihan T, Szekeres T, et al: Concordant changes of pyrimidine metabolism in blasts of two cases of acute myeloid leukemia after repeated treatment with ara-C in vivo. Leukemia 4:761-765, 1990
21. Hagenbeek A, Martens AC, Colly LP: In vivo development of cytosine arabinoside resistance in the BN acute myelocytic leukemia. Semin Oncol 14:202-206, 1987
22. Harris AL, Grahame-Smith DG, Potter CG, et al: Cytosine arabinoside deamination in human leukaemic myeloblasts and resistance to cytosine arabinoside therapy. Clin Sci (Colch) 60:191-198, 1981
23. Flasshove M, Frings W, Schroder JK, et al: Transfer of the cytidine deaminase cDNA into hematopoietic cells. Leuk Res 23:1047-1053, 1999
24. Gourdeau H, Bibeau L, Quellet F, et al: Comparative study of a novel nucleoside analogue (Troxatyl, troxacitabine, BCH-4556) and AraC against leukemic human tumor xenografts expressing high or low cytidine deaminase activity. Cancer Chemother Pharmacol 47:236-240, 2001
25. van Haperen VW, Veerman G, Vermerken JB, et al: Regulation of phosphorylation of deoxycytidine and 2′, 2′- difluorodeoxycytidine (gemcitabine); effects of cytidine 5′- triphosphate and uridine 5′-triphosphate in relation to chemosensitivity for 2′, 2′-difluorodeoxycytidine. Biochem Pharmacol 51:911-918, 1996
26. Weitman S, Marty J, Jolivet J, et al: The new dioxolane, (-)-2′-deoxy-3′-oxacytidine (BCH-4556, troxacitabine), has activity against pancreatic human tumor xenografts. Clin Cancer Res 6:1574-1578, 2000
27. Galmarini CM, Mackey JR, Dumontet C: Nucleoside analogues: Mechanisms of drug resistance and reversal strategies. Leukemia 15:875-890, 2001
28. Gunzburg WH, Salmons B: Novel clinical strategies for the treatment of pancreatic carcinoma. Trends Mol Med 7:30-37, 2001
29. Gourdeau H, Clarke ML, Quellet F, et al: Mechanisms of uptake and resistance to troxacitabine, a novel deoxycytidine nucleoside analogue, in human leukemic and solid tumor cell lines. Cancer Res 61:7217-7224, 2001
30. Gati WP, Paterson AR, Belch AR, et al: Es nucleoside transporter content of acute leukemia cells: Role in cell sensitivity to cytarabine (araC). Leuk Lymphoma 32:45-54, 1998
31. Grant S: Ara-C: cellular and molecular pharmacology. Adv Cancer Res 72:197-233, 1998
32. de Bono JS, Stephenson J Jr, Baker SD, et al: Troxacitabine, an L-stereoisomeric nucleoside analog, on a five-times-daily schedule: A phase I and pharmacokinetic study in patients with advanced solid malignancies. J Clin Oncol 20:96-109, 2002
33. Bodey GP, Coltman CA, Freireich EJ, et al: Chemotherapy of acute leukemia. Comparison of cytarabine alone and in combination with vincristine, prednisone, and cyclophosphamide. Arch Intern Med 133:260-266, 1974
34. Spriggs DR, Robbins G, Arthur K, et al: Prolonged high dose ARA-C infusions in acute leukemia. Leukemia 2:304-306, 1988
35. Tanaka M, Kanamori H, Yamaji S, et al: Low-dose cytarabine-induced hepatic and renal dysfunction in a patient with myelodysplastic syndrome. Anticancer Drugs 10:289-291, 1999
36. Carella AM, Berman E, Maraone MP, et al: Idarubicin in the treatment of acute leukemias. An overview of preclinical and clinical studies. Haematologica 75:159-169, 1990
37. Ardizzoni A, Hansen H, Dombernowsky P, et al: Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: A phase II study in patients with refractory and sensitive disease. The European Organization for Research and Treatment of Cancer Early Clinical Studies Group and New Drug Development Office, and the Lung Cancer Cooperative Group. J Clin Oncol 15:2090-2096, 1997
38. Giles F, Cortes J, Garcia-Manero G, et al: Phase I study of irofulven (MGI 114), an acylfulvene illudin analog, in patients with acute leukemia. Invest New Drugs 19:13-20, 2001
39. Giles FJ, Garcia-Manero G, O'Brien S, et al: Fatal hepatic venoocclusive disease on a phase I study of Mylotarg and Troxatyl in patients with refractory acute myeloid leukemia or myelodysplastic syndrome. Acta Haematol 108:164-167, 2002