Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with untreated or imatinib mesylate-resistant chronic myelogenous leukemia in blastic phase.
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.
Giles
Francis J
FJ
Department of Leukemia, M.D. Anderson Cancer Center, University of Texas, P.O. Box 428, Houston, TX 77030, USA. frankgiles@aol.com
Feldman
Eric J
EJ
Roboz
Gail J
GJ
Larson
Richard A
RA
Mamus
Steven W
SW
Cortes
Jorge E
JE
Verstovsek
Srdan
S
Faderl
Stefan
S
Talpaz
Moshe
M
Beran
Miloslav
M
Albitar
Maher
M
O'Brien
Susan M
SM
Kantarjian
Hagop M
HM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001549:Benzamides; D003596:Cytosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D004148:Dioxolanes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use*; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors; D011743:Pyrimidines / Q000627:therapeutic use*; D012074:Remission Induction; D016879:Salvage Therapy
D000970:Antineoplastic Agents; D001549:Benzamides; D004148:Dioxolanes; D010879:Piperazines; D011743:Pyrimidines; C074908:troxacitabine; D000068877:Imatinib Mesylate; D003596:Cytosine; D011505:Protein-Tyrosine Kinases