Phase 2 study of docetaxel in the treatment of childhood refractory acute leukemias: A Children's Oncology Group report

Background To determine the response rate and toxicity of docetaxel when administered as a 60 mg/m2 dose by 1 hr intravenous (IV) infusion weekly × 3 weeks in children with relapsed acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). Procedure Patients who were under the age of 22-year-old at the time of the original ALL or AML diagnosis and in a second relapse were accrued from August 2002 to May 2005 for this Children's Oncology Group (COG) phase 2 study (ADVL0023). Ten patients with ALL and two patients with AML were enrolled. Results There were no complete or partial responses observed. The most common grade 3 or 4 toxicities were hematologic followed by febrile neutropenia. One patient developed a dose limiting elevation in serum bilirubin, but no other significant hepatotoxicity was observed. Conclusions Docetaxel was not effective therapy for children with relapsed ALL at the dose and schedule tested. Pediatr Blood Cancer 2008;50:533–536. © 2007 Wiley-Liss, Inc.