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Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with untreated or imatinib mesylate-resistant chronic myelogenous leukemia in blastic phase.

Abstract
A phase II study of troxacitabine, a non-natural dioxolane nucleoside L-enantiomer, was conducted in patients with chronic myelogenous leukemia in blastic phase (CML-BP). Patients were untreated for BP, or treated with imatinib mesylate (IM) as sole prior therapy for BP. Troxacitabine was given as an intravenous infusion over 30 min daily for 5 days at a dose of 8.0 mg/m(2) per day. Thirty-one patients, 29 (93%) of whom had failed prior IM therapy, received 51 courses of therapy. Grade 3 or 4 toxicities included stomatitis (4%), hand-foot syndrome (18%), and skin rash (12%). Four patients (13%) responded. Troxacitabine-based combinations merit study in IM-resistant CML.
AuthorsFrancis J Giles, Eric J Feldman, Gail J Roboz, Richard A Larson, Steven W Mamus, Jorge E Cortes, Srdan Verstovsek, Stefan Faderl, Moshe Talpaz, Miloslav Beran, Maher Albitar, Susan M O'Brien, Hagop M Kantarjian
JournalLeukemia research (Leuk Res) Vol. 27 Issue 12 Pg. 1091-6 (Dec 2003) ISSN: 0145-2126 [Print] England
PMID12921945 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)
Chemical References
  • Antineoplastic Agents
  • Benzamides
  • Dioxolanes
  • Piperazines
  • Pyrimidines
  • troxacitabine
  • Imatinib Mesylate
  • Cytosine
  • Protein-Tyrosine Kinases
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
  • Benzamides
  • Cytosine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Dioxolanes (administration & dosage, adverse effects, therapeutic use)
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Imatinib Mesylate
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)
  • Male
  • Middle Aged
  • Piperazines (therapeutic use)
  • Protein-Tyrosine Kinases (antagonists & inhibitors)
  • Pyrimidines (therapeutic use)
  • Remission Induction
  • Salvage Therapy

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