Clinical Trials Logo
  1. Home
  2. Colonic Neoplasms
  3. NCT01681472

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

Colonic Neoplasms Clinical Trial

Official title:
A Single-Blind, Randomized Phase I/II Study of Pharmacokinetic and Pharmacodynamic Investigation of Modufolin® (60 or 200mg/m2) Compared to Levoleucovorin (60 or 200mg/m2) in Tumor, Adjacent Mucosa and Plasma for Patients With Colon Cancer

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01681472
Study type Interventional
Source Isofol Medical AB
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2012
Completion date August 2013
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT06041945 - Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology N/A
Not yet recruiting NCT02688699 - Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract Phase 4
Not yet recruiting NCT03175146 - A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely N/A
Completed NCT02529007 - Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening N/A
Not yet recruiting NCT01929499 - Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer Phase 2
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Completed NCT00535652 - Concentration of Ertapenem in Colorectal Tissue Phase 4
Terminated NCT00267787 - Molecular Genetic and Pathological Studies of Anal Tumors
Completed NCT05498051 - Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW. N/A
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Recruiting NCT03314896 - Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial) N/A
Not yet recruiting NCT02852915 - Laparoscopic Surgery for T4 Tumor of the Colon Cancer Phase 3
Not yet recruiting NCT02777437 - Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer Phase 2/Phase 3
Completed NCT00997802 - Japanese National Computed Tomographic (CT) Colonography Trial N/A
Completed NCT01056913 - NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery Phase 4
Completed NCT00537901 - First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study N/A
Completed NCT00470782 - Aerobic Capacity and Body Composition in Colon Cancer Patients N/A
Completed NCT00275210 - MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer Phase 3