Journal article
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, Vol.17(1), pp.1-9
1999
DOI: 10.1080/07357909909011711
PMID: 10999043
Abstract
Diarrhea 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 m2 plus 5-FU weekly for six doses followed by a 2-week rest. GM-CSF 250 mg m2 was administered subcutaneously 5 days each week. Cohorts were treated with 5-FU at 600, 700, and 800 mg m2 weekly. Twenty-nine patients were treated. The MTD of 5-FU in this schedule was 700 mg m2 week, with diarrhea dose-limiting. 5-FU delivered dose intensity at the MTD was 424 ± 23.7 mg m2 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.
Details
- Title: Subtitle
- 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
- Creators
- Neal J. Meropol - Roswell Park Cancer InstituteYoucef M. Rustum - Roswell Park Cancer InstitutePatrick J. Creaven - Roswell Park Cancer InstituteLeslie E. Blumenson - Roswell Park Cancer InstituteCheryl Frank - Roswell Park Cancer Institute
- Resource Type
- Journal article
- Publication Details
- Cancer investigation, Vol.17(1), pp.1-9
- Publisher
- Informa UK Ltd
- DOI
- 10.1080/07357909909011711
- PMID
- 10999043
- ISSN
- 0735-7907
- eISSN
- 1532-4192
- Language
- English
- Date published
- 1999
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359808302771
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