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Department of Hematology Oncology, Children‘s National Medical Center and Department of Pediatrics George Washington University School of Medicine, Washington, DC 20010 [N. L. S., R. B. M., G. H. R.]; Texas Children‘s Cancer Center, Houston, Texas 77030 [S. M. B.]; Pediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland 20892 [M. O‘B., F. M. B.]; Department of Preventive Medicine, University of Southern California, Los Angeles, California 90033 [M. K.]; and Department of Pediatric Hematology/Oncology, University of Michigan, Ann Arbor, Michigan 48109-0914 [R. H.]
Neutropenia is the dose-limiting toxicity of docetaxel in children. This Phase I trial was designed to determine the maximum tolerated dose, the dose-limiting toxicities, and the incidence and severity of other toxicities of docetaxel with filgrastim (G-CSF) support in children with refractory solid tumors. Docetaxel was administered as an i.v. infusion for 1 h every 21 days with a starting dose of 150 mg/m2 and an escalation to 185 mg/m2 and 235 mg/m2 in subsequent patient cohorts. G-CSF (5 µg/kg/day) was administered s.c., starting 48 h after docetaxel and continuing until the postnadir neutrophil count reached 10,000/µl. Seventeen patients received 27 courses of docetaxel with G-CSF support. Generalized erythematous desquamating skin rash and myalgias were dose-limiting at 235 mg/m2. Localized and generalized rashes were seen at all of the three dose levels. Neutropenia (median nadir, 95/µl) occurred at all of the dose levels but was brief in duration and not dose-limiting. Thrombocytopenia was minimal (median platelet count nadir, 139,000/µl), and the severity of neutropenia and thrombocytopenia did not seem to be related to the docetaxel dose. Other docetaxel-related toxicities included hemorrhage (associated with mucositis), sepsis, hypersensitivity reaction, transient elevation of liver enzymes, stomatitis, back pain, asthenia, and neuropathy. One minor response was observed in a patient with colon cancer. The maximum tolerated dose of docetaxel with G-CSF support in children is 185 mg/m2, which is 50% higher than the maximum tolerated dose of docetaxel alone in children and 85% higher than the recommended adult dose.
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