Study of the absorption and elimination of Modufolin® and Levoleucovorin on tumor, adjacent mucosa and plasma in patients with colon cancer.

• Conditions: Colon cancer; MedDRA version: 16.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000522-22-SE
• Lead Sponsor: Isofol Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-08
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients must have operable colon cancer that is amenable to curative surgery.

2.Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG). Performance Status scale. (See Protocol Attachment 2.)

3.Patients without contra indications for undergoing surgery.

4.For women: Must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after treatment; must have a negative serum or urine pregnancy test (within 7 days before enrolment) and must not be lactating.

5.For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after treatment.

6.Patients must sign an informed consent document.

7.Patient legally competent and able to communicate effectively with the study personnel as judged by the investigator.

8.Patient likely to co-operate during the study.

9.Patients must be at least 18 years of age.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

1.Concurrent administration of any other anti-tumor therapy.

2.Treatment within the last 30 days with a drug/device that has not received regulatory approval for any indication at the time of study entry.

3.Any intake of medication which could influence homocysteine, folate, and vitamin B12 status, within 30 days of surgery

4.Serious concomitant systemic disorders (e.g., active infection including HIV, cardiac disease) that in the opinion of the investigator would compromise the patient's ability to complete the study.

5.Are pregnant or breast-feeding.

6.Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.

7.History of significant neurological or mental disorder, including seizures or dementia.

8.Presence of clinically relevant (i.e., detectable by physical examination) third-space fluid collection (e.g., ascites, pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry.

9.Inability or unwillingness to be given Modufolin® or Levoleucovorin (Isovorin®).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): An exploratory evaluation of the tumor and mucosa concentrations of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF will be done respectively for comparisons between treatments. <br>;Timepoint(s) of evaluation of this end point: At the time of biopsy;Main Objective: •To compare [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF concentration in the tumor tissue and adjacent mucosa for the different treatment groups;Secondary Objective: •To explore if there is a difference in other pharmacokinetic parameters of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF calculated from plasma concentration. <br>•To study safety in terms of adverse events and laboratory measurements; haematology, clinical chemistry and urinalysis.<br>•To study gene expression in tumor and mucosa and its correlation to tissue concentration.<br>•To study homocystein and serum folate levels.