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Completed

NCT Number: NCT02244632

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

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.

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Key information

Conditions

Colorectal Neoplasm Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Odense University Hospital, Odense, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy

Treatment and study plan

Modufolin (arfolitixorin)

Drug

IV injection every second week for 8 weeks.

Other names: [6R] 5,10-methylenetetrahydrofolate, 6R-MTHF, 6R-methylene THF, ISO-901, arfolitixorin

Fluorouracil

Drug

IV injection every second week for 8 weeks.

Other names: 5-FU, 5-Flourouacil, 5-Fluoro-1H,3H-pyrimidine-2,4-dione, Adrucil

Oxaliplatin

Drug

IV infusion every second week for 8 weeks.

Other names: Eloxatin, [(1R,2R)-cyclohexane-1,2-diamine](ethanedioato-O,O')platinum(II), Olatin, Oxamed, Oxitropic

Irinotecan

Drug

IV infusion every second week for 8 weeks.

Other names: (+)-(4S)-4,11-Dietyl-4-hydroxi-9-[(4-piperidinopiperidino)karbonyloxi]-1H-pyrano[3¢,4¢:6,7]indolizino[1,2-b]kinolin-3,14-(4H,12H)dion, Irinosor, Campto, Namedica

Bevacizumab

Drug

IV infusion every second week for 8 weeks.

Other names: Avastin

Primary outcomes

  1. Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE)

    Time frame: The patients will be followed during 4 cycles of treatment (8 weeks).

    Primary safety variables will consist of monitoring and recording of DLTs and any significant AE that have led to adjustments in the therapy administration.

Sponsors and collaborators

Lead sponsor

Isofol Medical AB

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2014
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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