Weekly chronomodulated 48 h infusion of high-dose 5-fluorouracil modulated by methotrexate and (6S)-leucovorin in advanced colorectal cancer: a phase IB study.
In this phase IB study, 24 patients with advanced colorectal cancer were treated with escalating doses of weekly chronomodulated 48 h infusions of 5-fluorouracil (5-FU) biochemically modulated by methotrexate 40 mg/m2 and (6S)-leucovorin 8 x 45 mg orally. Two daily peak delivery periods (PDP), during which 65% of the daily dose was administered, were investigated: from 18.00 to 0.30 h and from 0.00 to 06.30 h. The maximal tolerated dose of 5-FU was 2800 mg/m2/48 h, with a PDP from 18.00 to 0.30 h.
Punt
C J
CJ
Department of Medical Oncology, University Hospital Nijmegen, The Netherlands.
Kamm
Y L
YL
Wagener
D J
DJ
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000931:Antidotes / Q000008:administration & dosage* / Q000627:therapeutic use*; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000627:therapeutic use*; D008875:Middle Aged; D013997:Time Factors
D000931:Antidotes; D000964:Antimetabolites, Antineoplastic; D002955:Leucovorin; D005472:Fluorouracil; D008727:Methotrexate