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

Leuk Res. 2003 Dec;27(12):1091-6. doi: 10.1016/s0145-2126(03)00094-8.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Benzamides
  • Cytosine / administration & dosage
  • Cytosine / adverse effects
  • Cytosine / analogs & derivatives
  • Cytosine / therapeutic use*
  • Dioxolanes / administration & dosage
  • Dioxolanes / adverse effects
  • Dioxolanes / 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

Substances

  • Antineoplastic Agents
  • Benzamides
  • Dioxolanes
  • Piperazines
  • Pyrimidines
  • troxacitabine
  • Imatinib Mesylate
  • Cytosine
  • Protein-Tyrosine Kinases