PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
The purpose of this study is to compare the concentration of four different metabolites in
 the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two
 different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60
 and 200 mg/m2).
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).
Main Inclusion Criteria:

 -  Operable colon cancer amenable to curative surgery.

 -  Performance status of 0 to 1

 -  Informed consent form

 -  Patients must be at least 18 years of age.

 Main Exclusion Criteria:

 -  Any concurrent other anti-tumor therapy

 -  Any prohibited concomitant medication within 30 days of surgery

 -  Pregnancy or breast-feeding.

 -  Second primary malignancy