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

Isofol Medical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colonic Neoplasms

Treatments: Drug: 6R-MTHF (arfolitixorin) 200 mg/m2; Drug: Levoleucovorin 60 mg/m2; Drug: 6R-MTHF (arfolitixorin) 60 mg/m2; Drug: Levoleucovorin 200 mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01681472

2012-000522-22 (EudraCT Number)

ISO-CC-002

Details and patient eligibility

About

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).

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 4 patient groups

Levoleucovorin 200 mg/m2

Active Comparator group

Description:

One i.v. bolus injection of study drug after the patient has been anaesthetized.

Treatment:

Drug: Levoleucovorin 200 mg/m2

Levoleucovorin 60 mg/m2

Active Comparator group

Description:

One i.v. bolus injection of study drug after the patient has been anaesthetized.

Treatment:

Drug: Levoleucovorin 60 mg/m2

6R-MTHF 200 mg/m2

Experimental group

Description:

One i.v. bolus injection of study drug after the patient has been anaesthetized.

Treatment:

Drug: 6R-MTHF (arfolitixorin) 200 mg/m2

6R-MTHF 60 mg/m2

Experimental group

Description:

One i.v. bolus injection of study drug after the patient has been anaesthetized.

Treatment:

Drug: 6R-MTHF (arfolitixorin) 60 mg/m2