Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer

Colorectal Neoplasm Clinical Trial

Official title:

An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin®) in Combination With a Fixed Dose of 5-Fluorouracil (5-FU) Alone or Together With a Fixed Dose of Oxaliplatin or Irinotecan in Patients With Stage IV Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244632
• Other study ID #: ISO-CC-005
• Secondary ID: 2014-001862-84
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2014
• Est. completion date: January 30, 2020

Study information

• Verified date: September 2020
• Source: Isofol Medical AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to characterise the tolerability of Modufolin (arfolitixorin) in combination with 5-FU alone, in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in combination with 5-FU, Oxaliplatin and Bevacizumab.

Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment.

Description:

The study will investigate the tolerability of Modufolin at four (4) different dose levels (30 to 240 mg/m2) in therapy combinations with the chemotherapeutic agents 5-FU, Oxaliplatin +/- bevcizumab, and Irinotecan.

When the selected phase 2 dose is determined, 40 additional patients, will be included in the study in order to acquire more data on the safety and tolerability of Modufolin at this dose level. Twenty (20) of these additional patients will be treated in with Oxaliplatin, 20 with Irinotecan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms
• Neoplasms

Intervention

Drug:
• Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
• Fluorouracil
IV injection every second week for 8 weeks.
• Oxaliplatin
IV infusion every second week for 8 weeks.
• Irinotecan
IV infusion every second week for 8 weeks.
• Bevacizumab
IV infusion every second week for 8 weeks.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense
Greece	251 General Airforce Hospital	Athens
Greece	Medical School University of Athens, Aretaieio Hospital	Athens
Greece	Metropolitan General Hospital	Athens
Greece	University Genral Hospital Attikon	Athens
Greece	University General Hospital of Heraklion	Iráklion
Norway	Oslo University Hospital - Radiumhospitalet	Oslo
Norway	Oslo University Hospital - Ullevål	Oslo
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Skaraborg hospital	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
Isofol Medical AB

Countries where clinical trial is conducted

Denmark,  Greece,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE)	Primary safety variables will consist of monitoring and recording of DLTs and any significant AE that have led to adjustments in the therapy administration.	The patients will be followed during 4 cycles of treatment (8 weeks).