Abstract
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.
Publication types
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Research Support, Non-U.S. Gov't
MeSH terms
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Adenocarcinoma / drug therapy*
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Adenocarcinoma / pathology
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Adult
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Aged
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Antidotes / administration & dosage*
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Antidotes / therapeutic use*
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Antimetabolites, Antineoplastic / administration & dosage*
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Antimetabolites, Antineoplastic / adverse effects
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Antimetabolites, Antineoplastic / therapeutic use*
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Clinical Trials, Phase I as Topic
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Colorectal Neoplasms / drug therapy*
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Colorectal Neoplasms / pathology
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Female
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Fluorouracil / administration & dosage*
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Fluorouracil / adverse effects
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Fluorouracil / therapeutic use*
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Humans
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Infusions, Intravenous
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Leucovorin / administration & dosage*
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Leucovorin / therapeutic use*
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Male
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Methotrexate / administration & dosage*
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Methotrexate / therapeutic use*
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Middle Aged
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Time Factors
Substances
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Antidotes
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Antimetabolites, Antineoplastic
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Leucovorin
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Fluorouracil
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Methotrexate