PK/PD Investigation of Modufolin® in Plasma, Tumor and Adjacent Mucosa in Patients With Colon Cancer
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The purpose of this study is to compare the concentration of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different does of Modufolin® and Levoleucovorin (Isovorin®) respectively (60 and 200 mg/m2).
A Single-Blind, Randomized Phase I/II Study of Pharmacokinetic and Pharmacodynamic Investigation of Modufolin® (60 or 200 mg/m2) Compared to Levoleucovorin (60 or 200 mg/m2) in Tumor, Adjacent Mucosa and Plasma for Patients With Colon Cancer
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have operable colon cancer that is amenable to curative surgery.