Conditions: Colonic Neoplasms
Keywords: Colon cancer 5,10-methylenetetrahydrofolate Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Therapeutic Uses Pharmacokinetics Pharmacodynamics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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).

Arms:
arm 1: One i.v. bolus injection of study drug after the patient has been anaesthetized. arm 2: One i.v. bolus injection of study drug after the patient has been anaesthetized. arm 3: One i.v. bolus injection of study drug after the patient has been anaesthetized. arm 4: One i.v. bolus injection of study drug after the patient has been anaesthetized.

Interventions: intervention 1: 6R-MTHF (arfolitixorin) 200 mg/m2 intervention 2: Levoleucovorin 200 mg/m2 intervention 3: 6R-MTHF (arfolitixorin) 60 mg/m2 intervention 4: Levoleucovorin 60 mg/m2
Intervention descriptions: intervention 1: i.v. bolus injection intervention 2: i.v. bolus injection intervention 3: i.v. bolus injection intervention 4: i.v. bolus injection

Protocol document: