This is an archive of papers published by the staff and faculty of Fox Chase Cancer Center. For questions about content, please contact Talbot Research Library
Last updated on
Meropol NJ , Rustum YM , Creaven PJ , Blumenson LE , Frank C
Phase I and pharmacokinetic study of weekly 5-fluorouracil administered with granulocyte-macrophage colony-stimulating factor and high-dose leucovorin: A potential role for growth factor as mucosal protectant
Cancer Investigation. 1999 ;17(1) :1-9
AbstractDiarrhea is dose-limiting with weekly 5-fluorouracil (5-FU) plus high-dose leucovorin (LV). Granulocyte-macrophage colony- stimulating factor (GM-CSF) has been associated with a decrease in chemotherapy-associated mucosal toxicity. This study was conducted to determine the maximum tolerated dose (MTD) of weekly 5-FU when administered with GM-CSF and high-dose LV. Patients were treated with intravenous LV 500 mg/m(2) plus 5-FU weekly for siv doses followed hy a 2-week rest. GM-CSF 250 mg/m(2) was administered subcutaneously 5 days each week. Cohorts were treated with 5-FU at 600, 700 and 800 mg/m(2) weekly. Twenty-nine patients were treated. The MTD of 5-FU in this schedule was 700 mg/m(2)/week, with diarrhea dose- limiting. 5-FU delivered dose intensity at the MTD was 424 +/- 23.7 mg/m(2)/week, including rest periods. 5-FU and LV pharmacokinetics were not altered by concurrent treatment with GM-CSF. In a weekly schedule with high-dose LV and GM-CSF, the MTD of 5-FU and 5-FU delivered dose Intensity were higher than previously reported with 5-FU and LV administered without GM- CSF.
NotesTimes Cited: 0 English Article 165HD CANCER INVEST