Document Detail

Troxacitabine, a novel dioxolane nucleoside analog, has activity in patients with advanced leukemia.
MedLine Citation:
PMID:  11157029     Owner:  NLM     Status:  MEDLINE    
PURPOSE: To investigate the toxicity profile, activity, and pharmacokinetics of a novel L-nucleoside analog, troxacitabine (BCH-4556), in patients with advanced leukemia. PATIENTS AND METHODS: Patients with refractory or relapsed acute myeloid (AML) or lymphocytic (ALL) leukemia, myelodysplastic syndromes (MDS), or chronic myelogenous leukemia in blastic phase (CML-BP). Troxacitabine was given as an intravenous infusion over 30 minutes daily for 5 days. The starting dose was 0.72 mg/m(2)/d (3.6 mg/m(2)/course). Courses were given every 3 to 4 weeks according to toxicity and antileukemic efficacy. The dose was escalated by 50% until grade 2 toxicity was observed, and then by 30% to 35% until the dose-limiting toxicity (DLT) was defined. RESULTS: Forty-two patients (AML: 31 patients; MDS: six patients [five MDS + one CMML]; ALL: four patients; CML-BP: one patient) were treated. Median age was 61 years (range, 23 to 79 years), and 29 patients were males. Stomatitis and hand-foot syndrome were the DLTs. The MTD was defined as 8 mg/m(2)/d. The pharmacokinetic behavior of troxacitabine is linear over the dose range of 0.72 to 10.0 m/m(2). Approximately 69% of troxacitabine was excreted as unchanged drug in the urine. Marrow hypoplasia occurred between days 14 and 28 in 73% of AML patients. Three complete remissions and one partial remission were observed in 30 assessable AML patients. One MDS patient achieved a hematologic improvement. A patient with CML-BP achieved a return to chronic phase disease. CONCLUSION: Troxacitabine has a unique metabolic and pharmacokinetic profile and significant antileukemic activity. DLTs were stomatitis and hand-foot syndrome. Troxacitabine merits further study in hematologic malignancies.
F J Giles; J E Cortes; S D Baker; D A Thomas; S O'Brien; T L Smith; M Beran; C Bivins; J Jolivet; H M Kantarjian
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article    
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  19     ISSN:  0732-183X     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2001 Feb 
Date Detail:
Created Date:  2001-02-22     Completed Date:  2001-03-15     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  762-71     Citation Subset:  IM    
Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston 77030-4095, USA.
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MeSH Terms
Acute Disease
Antineoplastic Agents / adverse effects*,  pharmacokinetics,  therapeutic use
Blast Crisis / drug therapy,  metabolism
Cytosine / adverse effects*,  analogs & derivatives*,  pharmacokinetics,  therapeutic use
Dioxolanes / adverse effects*,  pharmacokinetics,  therapeutic use
Dose-Response Relationship, Drug
Leukemia / drug therapy*,  metabolism
Leukemia, Myelogenous, Chronic, BCR-ABL Positive / drug therapy,  metabolism,  pathology
Leukemia, Myeloid / drug therapy,  metabolism
Middle Aged
Myelodysplastic Syndromes / drug therapy,  metabolism
Precursor Cell Lymphoblastic Leukemia-Lymphoma / drug therapy,  metabolism
Reg. No./Substance:
0/Antineoplastic Agents; 0/Dioxolanes; 145918-75-8/troxacitabine; 71-30-7/Cytosine

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