PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isofol Medical AB
• Treatments: Leucovorin; Levoleucovorin; Tetrahydrofolates

Criteria

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