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/m(2) dose by 1 hr intravenous (IV) infusion weekly x 3 weeks in children with relapsed acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).


METHODS
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.
Franklin
Janet L
JL
Childrens Hospital Los Angeles, Los Angeles, California, USA.
Seibel
Nita L
NL
Krailo
Mark
M
Fu
Cecilia
C
Adamson
Peter C
PC
Reaman
Gregory
G
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001855:Bone Marrow Diseases / Q000139:chemically induced; D002648:Child; D002675:Child, Preschool; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D007938:Leukemia / Q000188:drug therapy*; D007951:Leukemia, Myeloid / Q000188:drug therapy; D008297:Male; D009503:Neutropenia / Q000139:chemically induced; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy; D016879:Salvage Therapy; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel