{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T19:22:11Z","timestamp":1760296931381},"reference-count":39,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2003,3,15]]},"abstract":"<jats:p> Purpose: Troxacitabine has significant single-agent activity. This study was conducted to define the dose-limiting toxicities (DLTs) of its combination with cytarabine (ara-C), idarubicin, or topotecan. <\/jats:p><jats:p> Patients and Methods: Patients with refractory acute myeloid leukemia (AML), advanced myelodysplastic syndromes (MDS), or chronic myelogenous leukemia in blastic phase (CML-BP) were initially randomly assigned to receive troxacitabine 5.0 mg\/m<jats:sup>2<\/jats:sup> by intravenous (IV) infusion over 30 minutes on days 1 to 5 with ara-C 1.0 mg\/m<jats:sup>2<\/jats:sup>\/d IV over 2 hours on days 1 to 5, idarubicin 12 mg\/m<jats:sup>2<\/jats:sup> by 5 minute IV infusion on days 1 to 3, or topotecan 1.0 mg\/m<jats:sup>2<\/jats:sup> as an continuous IV infusion on days 1 to 5. Doses were then adjusted to define DLT for each combination. <\/jats:p><jats:p> Results: Eighty-seven patients (68 AML, eight MDS, 11 CML-BP) were treated. DLTs were hepatic transaminitis, hyperbilirubinemia, and hand foot syndrome (HFS) on the troxacitabine plus ara-C combination. The recommended phase II doses were 6 mg\/m<jats:sup>2<\/jats:sup> once a day for 5 days and 1.0g\/m<jats:sup>2<\/jats:sup> once a day for 5 days, respectively. DLTs were diarrhea, rash, and mucositis on the troxacitabine plus topotecan combination. The recommended phase II doses were 4 mg\/m<jats:sup>2<\/jats:sup> once a day for 5 days and 0.75 mg\/m<jats:sup>2<\/jats:sup> once a day for 5 days, respectively. DLTs were HFS, rash, and mucositis on the troxacitabine plus idarubicin combination. The recommended phase II doses were 4 mg\/m<jats:sup>2<\/jats:sup> once a day for 5 days and 9 mg\/m<jats:sup>2<\/jats:sup> once a day for 3 days, respectively. Among 74 evaluable patients with AML or MDS, 10 (13%) achieved complete remission and four (5%) had hematologic improvement. Two of 11 (18%) evaluable patients with CML-BP returned to chronic phase. <\/jats:p><jats:p> Conclusion: Troxacitabine-based combinations had significant antileukemic activity. <\/jats:p>","DOI":"10.1200\/jco.2003.04.023","type":"journal-article","created":{"date-parts":[[2003,3,13]],"date-time":"2003-03-13T17:44:34Z","timestamp":1047577474000},"page":"1050-1056","source":"Crossref","is-referenced-by-count":32,"title":["Randomized Phase I\/II Study of Troxacitabine Combined With Cytarabine, Idarubicin, or Topotecan in Patients With Refractory Myeloid Leukemias"],"prefix":"10.1200","volume":"21","author":[{"given":"Francis J.","family":"Giles","sequence":"first","affiliation":[{"name":"From the Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX; Division of Hematology, University of Southern California Keck Medical School; and Norris Cancer Center, Los Angeles, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Faderl","sequence":"additional","affiliation":[{"name":"From the Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX; Division of Hematology, University of Southern California Keck Medical School; and Norris Cancer Center, Los Angeles, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah A.","family":"Thomas","sequence":"additional","affiliation":[{"name":"From the Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX; Division of Hematology, University of Southern California Keck Medical School; and Norris Cancer Center, Los Angeles, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge E.","family":"Cortes","sequence":"additional","affiliation":[{"name":"From the Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX; Division of Hematology, University of Southern California Keck Medical School; and Norris Cancer Center, Los Angeles, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guillermo","family":"Garcia-Manero","sequence":"additional","affiliation":[{"name":"From the Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX; 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