Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors

Abstract

This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 μg with or without intravenous (IV) iron in treating anemia in patients receiving multicycle chemotherapy. This Phase 2, double‐blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 μg (n = 62), darbepoetin alfa 300 μg plus IV iron (n = 60), darbepoetin alfa 500 μg (n = 60), or darbepoetin alfa 500 μg plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels ≤10 g dL−1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin (≥11 g dL−1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT‐F) score from baseline to end of study. Safety was evaluated by incidence of adverse events. No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed, therefore, results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups. Similar proportions of patients receiving darbepoetin alfa 300 or 500 μg achieved target hemoglobin (75 and 78%, respectively); Kaplan–Meier median time to target hemoglobin was 10 and 8 weeks, respectively. More patients receiving IV iron (82%) than not receiving IV iron (72%) achieved hemoglobin target. Adverse events profiles were similar for darbepoetin alfa treatment groups. Transient anaphylactoid reactions were reported in two patients receiving IV iron. Darbepoetin alfa at 300 μg Q3W and 500 μg Q3W showed similar benefit, while added IV iron improved treatment response in these patients. Am. J. Hematol., 2010. © 2010 Wiley‐Liss, Inc.

Preclinical Analysis of Tasidotin HCl in Ewing's Sarcoma, Rhabdomyosarcoma, Synovial Sarcoma, and Osteosarcoma

“…A recent phase II trial of docetaxel in recurrent solid tumors suggest that, even in patients heavily pretreated with vincristine, tubulin may still be an effective target in the relapse setting as well (21). The activity of these agents may be enhanced when used in combination with other agents.…”

Favorable Response of Heavily Treated Wilms’ Tumor to Paclitaxel and Carboplatin

“…The other received second-linechemotherapyofpaclitaxelaloneaftercarboplatin, etoposide, doxorubicin, and vincristine [14]. Docetaxel with a similar mechanism of paclitaxel, which binds tubulin and stabilizes microtubules, was not effective in 8 patients with Wilms' tumor [15]. A phase II study of ixabepilone, a newmicrotubule-stabilizingagent,wasrecentlyperformedin children and young adults with refractory solid tumors including six patients with Wilms' tumor; however, no responsewasobserved [16].Thus,theeffectivenessoftaxanes againstWilms'tumorisnotestablished.Thepatientpresented here had received chemotherapy including carboplatin and cisplatin between 2001 and 2004; and the tumor did not respond to a combination of carboplatin and irinotecan in 2008.Whencarboplatinwascombinedwithirinotecanorpaclitaxel,thedoseandscheduleofadministrationofcarboplatin (AUC = 5 or 4 on day 1, respectively) were similar.…”

Multidisciplinary Management of Primary Tumors of the Vertebral Column

“…Docetaxel is a cytotoxic agent that stabilizes microtubules against depolymerization and results in cell cycle arrest. The use of docetaxel as a single agent has demonstrated modest responses in patients with osteosarcoma [162][163][164]. Navid and colleagues retrospectively reviewed their institutional experience using a combination of gemcitabine and docetaxel in the treatment of patients with pediatric sarcoma.…”