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

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ClinicalTrials.gov Identifier: NCT02244632
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Isofol Medical AB

Brief Summary:

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 or disease Intervention/treatment Phase
Colorectal Neoplasm Drug: Modufolin Drug: Fluorouracil Drug: Oxaliplatin Drug: Irinotecan Drug: Bevacizumab Phase 1 Phase 2

Detailed 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, 20 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. Ten (10) of these additional patients will be treated in with Oxaliplatin, 10 with Irinotecan.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
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
Actual Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: MOFIRI
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




Primary Outcome Measures :
  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.



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

Inclusion Criteria:

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy


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 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

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 Posted: September 19, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
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