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Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors
A report from the Children's Oncology Group
Article first published online: 10 MAR 2006
Copyright © 2006 American Cancer Society
Volume 106, Issue 8, pages 1821–1828, 15 April 2006
How to Cite
Zwerdling, T., Krailo, M., Monteleone, P., Byrd, R., Sato, J., Dunaway, R., Seibel, N., Chen, Z., Strain, J. and Reaman, G. (2006), Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors. Cancer, 106: 1821–1828. doi: 10.1002/cncr.21779
- Issue published online: 4 APR 2006
- Article first published online: 10 MAR 2006
- Manuscript Accepted: 26 OCT 2005
- Manuscript Revised: 24 OCT 2005
- Manuscript Received: 14 JUL 2005
- Phase II;
- recurrent pediatric solid tumors;
- Ewing sarcoma activity;
Docetaxel, which is an antitubulin agent, has demonstrable activity against murine and human tumors. The current study was designed to determine response rates to docetaxel in various strata of recurrent solid tumors of childhood and to assess toxicity in a group of patients who were assigned to receive it.
Docetaxel was given at a dose of 125 mg/m2 once every 21 days as a 1-hour intravenous infusion for a maximum of 12 courses. From January 1997 to November 2001, 109 male patients and 68 female patients (total, 177 patients) were enrolled, and 173 patients were eligible. The median patient age at entry was 13 years (range, 1-27 yrs). One hundred sixty patients were evaluable for response.
There were no deaths attributable to study drug. Hematologic toxicity was common during therapy. Dermatologic, neurologic, pulmonary, and infectious side effects as well as edema were significant. One patient each had acute myeloid leukemia, acute lymphoid leukemia, and high-grade glioma reported as secondary malignancies. One patient with osteosarcoma and 1 patient with rhabdomyosarcoma achieved a complete response. Partial responses were observed in patients with Ewing sarcoma (3 patients), osteosarcoma (1 patient), squamous cell carcinoma (1 patient), and medulloblastoma (1 patient). Seventeen patients had stable disease. The 1-year and 5-year overall survival rates for the 160 evaluable patients were 24% (standard error = 4%) and 6% (standard error = 2%), respectively.
Docetaxel demonstrated activity in patients with recurrent Ewing sarcoma but was found to be ineffective for treating the other types of recurrent solid tumors that were studied. Cancer 2006. © 2006 American Cancer Society.