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Modufolin® in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer

This study is currently recruiting participants.
Verified September 2017 by Isofol Medical AB
Sponsor:
ClinicalTrials.gov Identifier:
NCT02244632
First Posted: September 19, 2014
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Isofol Medical AB
  Purpose

The purpose is to characterise the tolerability of Modufolin 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.


Condition Intervention Phase
Colorectal Neoplasm Drug: Modufolin Drug: Fluorouracil Drug: Oxaliplatin Drug: Irinotecan Drug: Bevacizumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Isofol Medical AB:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Actual Study Start Date: September 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modufolin / Nordic FLV
Modufolin in combination with 5-Fluorouracil only.
Drug: Modufolin
IV injection every second week for 8 weeks.
Other Names:
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-MTHF
  • 6R-methylene THF
  • ISO-901
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
  • Adrucil
Experimental: Modufolin / Nordic FLOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
Drug: Modufolin
IV injection every second week for 8 weeks.
Other Names:
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-MTHF
  • 6R-methylene THF
  • ISO-901
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
  • Adrucil
Drug: Oxaliplatin
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
Experimental: Modufolin / Nordic FLIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan.
Drug: Modufolin
IV injection every second week for 8 weeks.
Other Names:
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-MTHF
  • 6R-methylene THF
  • ISO-901
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
  • Adrucil
Drug: Irinotecan
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
Experimental: MOFOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
Drug: Modufolin
IV injection every second week for 8 weeks.
Other Names:
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-MTHF
  • 6R-methylene THF
  • ISO-901
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
  • Adrucil
Drug: Oxaliplatin
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
Experimental: MOFOX / Bevacizumab
Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
Drug: Modufolin
IV injection every second week for 8 weeks.
Other Names:
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-MTHF
  • 6R-methylene THF
  • ISO-901
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
  • Adrucil
Drug: Oxaliplatin
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
Drug: Bevacizumab
IV infusion every second week for 8 weeks.
Other Name: Avastin

Detailed Description:

The study will investigate the tolerability of Modufolin at four (4) dose levels (30, 60, 120 and 240 mg/m2) in two (2) treatment combinations of the chemotherapeutic agents 5-FU and Oxaliplatin during eight (8) weeks of treatment.

The tolerability of the two (2) lower doses of Modufolin (30 and 60 mg/m2) will also be investigated in one treatment combination with the chemotherapeutic agent Irinotecan.

The tolerability of the Modufolin dose that is assessed as having the most favourable profile will then be investigated in a treatment combination of the 5-FU, Oxaliplatin and Bevacizumab during eight (8) weeks of treatment.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244632


Contacts
Contact: Lisa Skintemo +46 (0) 702 43 37 65 lisa.skintemo@isofolmedical.com

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark
Greece
251 General Airforce Hospital Recruiting
Athens, Greece
IASO General Hospital Recruiting
Athens, Greece
Medical School University of Athens, Aretaieio Hospital Recruiting
Athens, Greece
University Genral Hospital Attikon Active, not recruiting
Athens, Greece
University General Hospital of Heraklion Recruiting
Iráklion, Greece
Norway
Oslo University Hospital Completed
Oslo, Norway
Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 461 85
Contact: Göran Carlsson, MD         
Principal Investigator: Göran Carlsson, MD         
Skaraborg hospital Recruiting
Skövde, Sweden
Sponsors and Collaborators
Isofol Medical AB
Investigators
Principal Investigator: Göran Carlsson, MD Sahlgrenska University Hospital, Sweden
  More Information

Responsible Party: Isofol Medical AB
ClinicalTrials.gov Identifier: NCT02244632     History of Changes
Other Study ID Numbers: ISO-CC-005
2014-001862-84 ( EudraCT Number )
First Submitted: September 17, 2014
First Posted: September 19, 2014
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Isofol Medical AB:
Colorectal cancer
Colorectal carcinoma
Colorectal tumors
Intestinal Neoplasm
Gastrointestinal Neoplasm
Gastrointestinal disease
5,10-methylenetetrahydrofolate
Tetrahydrofolates
Therapeutic uses
Pharmacokinetics
Pharmacodynamics
Safety assessments

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Irinotecan
Camptothecin
Fluorouracil
Tetrahydrofolates
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic