Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer
NCT ID: NCT02244632
Last Updated: 2020-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
105 participants
INTERVENTIONAL
2014-09-30
2020-01-30
Brief Summary
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Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modufolin / Nordic FLV
Modufolin in combination with 5-Fluorouracil only.
Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Fluorouracil
IV injection every second week for 8 weeks.
Modufolin / Nordic FLOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
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.
Modufolin / Nordic FLIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan.
Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Fluorouracil
IV injection every second week for 8 weeks.
Irinotecan
IV infusion every second week for 8 weeks.
MOFOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
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.
MOFOX / Bevacizumab
Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
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.
Bevacizumab
IV infusion every second week for 8 weeks.
MOFIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan
Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Fluorouracil
IV injection every second week for 8 weeks.
Irinotecan
IV infusion every second week for 8 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Isofol Medical AB
INDUSTRY
Responsible Party
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Principal Investigators
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Göran Carlsson, MD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
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
Irakleio, , Greece
Oslo University Hospital - Radiumhospitalet
Oslo, , Norway
Oslo University Hospital - Ullevål
Oslo, , Norway
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skaraborg hospital
Skövde, , Sweden
Countries
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References
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Carlsson G, Koumarianou A, Guren TK, Haux J, Katsaounis P, Kentepozidis N, Pfeiffer P, Braendengen M, Mavroudis D, Taflin H, Skintemo L, Tell R, Papadimitriou C. A phase I/II study of arfolitixorin and 5-fluorouracil in combination with oxaliplatin (plus or minus bevacizumab) or irinotecan in metastatic colorectal cancer. ESMO Open. 2022 Oct;7(5):100589. doi: 10.1016/j.esmoop.2022.100589. Epub 2022 Sep 29.
Taflin H, Odin E, Carlsson G, Tell R, Gustavsson B, Wettergren Y. Plasma deoxyuridine as a surrogate marker for toxicity and early clinical response in patients with metastatic colorectal cancer after 5-FU-based therapy in combination with arfolitixorin. Cancer Chemother Pharmacol. 2021 Jan;87(1):31-41. doi: 10.1007/s00280-020-04173-2. Epub 2020 Oct 24.
Other Identifiers
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2014-001862-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISO-CC-005
Identifier Type: -
Identifier Source: org_study_id
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