PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer

• Status: Active, not recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open randomized single site Pharmacokinetic and Pharmacodynamic study,of Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in blood, tumor and adjacent mucosa from patients with colon cancer

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vastra Gotaland Region
• Treatments: Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

1. Patients must have an operable colon cancer that is determined to colorectal surgery

2. Patients must sign an informed consent document

3. Patients must be ≥ 18 years of age

4. Fertile women must present a negative pregnancy test and use secure contraceptives during and three months after treatment

Exclusion Criteria:

1. Neo-adjuvant chemotherapy within the last 30 days

2. 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

3. Female patients: currently pregnant or breast-feeding

4. Patient with epileptic medication, such as fenobarbital, primidon, fenytoin och succinimider