PURPOSE: To perform a phase 1 trial to determine the maximum tolerated dose and the dose-limiting toxicities of paclitaxel in children with refractory or recurrent solid tumors. Paclitaxel was administered twice weekly, increasing from four to six doses every 21 to 28 days. METHODS: Paclitaxel was administered as a 3-hour intravenous infusion twice weekly. The initial dose was fixed at 50 mg/m2/dose twice weekly for 2 weeks (four doses), every 21 days. The number of twice-weekly doses per course was increased to six in the next cohort. In subsequent cohorts, the number of twice-weekly doses per course was fixed at six, every 28 days, and dosage was increased in 25% increments. RESULTS: Sixteen assessable patients were enrolled at three levels. Neutropenia was the dose-limiting toxicity at 65 mg/m2/dose, twice weekly x 6 doses, every 28 days. Nonhematologic toxicities were minor. No antitumor responses were observed. CONCLUSIONS: Protracted twice-weekly dosing of paclitaxel is limited by neutropenia. The maximum tolerated dose of paclitaxel administered twice weekly x 6 doses, every 28 days, was 50 mg/m2/dose.
PURPOSE: To perform a phase 1 trial to determine the maximum tolerated dose and the dose-limiting toxicities of paclitaxel in children with refractory or recurrent solid tumors. Paclitaxel was administered twice weekly, increasing from four to six doses every 21 to 28 days. METHODS:Paclitaxel was administered as a 3-hour intravenous infusion twice weekly. The initial dose was fixed at 50 mg/m2/dose twice weekly for 2 weeks (four doses), every 21 days. The number of twice-weekly doses per course was increased to six in the next cohort. In subsequent cohorts, the number of twice-weekly doses per course was fixed at six, every 28 days, and dosage was increased in 25% increments. RESULTS: Sixteen assessable patients were enrolled at three levels. Neutropenia was the dose-limiting toxicity at 65 mg/m2/dose, twice weekly x 6 doses, every 28 days. Nonhematologic toxicities were minor. No antitumor responses were observed. CONCLUSIONS: Protracted twice-weekly dosing of paclitaxel is limited by neutropenia. The maximum tolerated dose of paclitaxel administered twice weekly x 6 doses, every 28 days, was 50 mg/m2/dose.
Authors: Peter J Houghton; Raushan T Kurmasheva; E Anders Kolb; Richard Gorlick; John M Maris; Jianrong Wu; Zeen Tong; Michael A Arnold; Moumita Chatterjee; Terence M Williams; Malcolm A Smith Journal: Pediatr Blood Cancer Date: 2015-03-23 Impact factor: 3.167
Authors: Terzah M Horton; Matthew M Ames; Joel M Reid; Mark D Krailo; Thomas Pendergrass; Revonda Mosher; Gregory H Reaman; Nita L Seibel Journal: Pediatr Blood Cancer Date: 2008-04 Impact factor: 3.167
Authors: Justus Lieber; Carmen Eicher; Julia Wenz; Bettina Kirchner; Steven W Warmann; Jörg Fuchs; Sorin Armeanu-Ebinger Journal: BMC Cancer Date: 2011-08-19 Impact factor: 4.430
Authors: E Anders Kolb; Richard Gorlick; Stephen T Keir; John M Maris; Min H Kang; C Patrick Reynolds; Richard B Lock; Hernan Carol; Jianrong Wu; Raushan T Kurmasheva; Peter J Houghton; Malcolm A Smith Journal: Pediatr Blood Cancer Date: 2014-11-18 Impact factor: 3.838