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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Levoleucovorin 200 mg/m2

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

Group Type ACTIVE_COMPARATOR

Levoleucovorin 200 mg/m2

Intervention Type DRUG

i.v. bolus injection

Levoleucovorin 60 mg/m2

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

Group Type ACTIVE_COMPARATOR

Levoleucovorin 60 mg/m2

Intervention Type DRUG

i.v. bolus injection

6R-MTHF 200 mg/m2

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

Group Type EXPERIMENTAL

6R-MTHF (arfolitixorin) 200 mg/m2

Intervention Type DRUG

i.v. bolus injection

6R-MTHF 60 mg/m2

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

Group Type EXPERIMENTAL

6R-MTHF (arfolitixorin) 60 mg/m2

Intervention Type DRUG

i.v. bolus injection

Interventions

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6R-MTHF (arfolitixorin) 200 mg/m2

i.v. bolus injection

Intervention Type DRUG

Levoleucovorin 200 mg/m2

i.v. bolus injection

Intervention Type DRUG

6R-MTHF (arfolitixorin) 60 mg/m2

i.v. bolus injection

Intervention Type DRUG

Levoleucovorin 60 mg/m2

i.v. bolus injection

Intervention Type DRUG

Other Intervention Names

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Modufolin® ISO-901 [6R] 5,10-methylenetetrahydrofolate arfolitixorin Isovorin® Modufolin® ISO-901 [6R] 5,10-methylenetetrahydrofolate arfolitixorin Isovorin®

Eligibility Criteria

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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.

Exclusion Criteria

* Any concurrent other anti-tumor therapy
* Any prohibited concomitant medication within 30 days of surgery
* Pregnancy or breast-feeding.
* Second primary malignancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No