Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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, 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Modufolin / Nordic FLV Modufolin in combination with 5-Fluorouracil only. |
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
|
| Experimental: Modufolin / Nordic FLOX Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime |
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
Drug: Oxaliplatin
IV infusion every second week for 8 weeks.
Other Names:
|
| Experimental: Modufolin / Nordic FLIRI Modufolin in combination with 5-Fluorouracil and Irinotecan. |
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
Drug: Irinotecan
IV infusion every second week for 8 weeks.
Other Names:
|
| Experimental: MOFOX Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime |
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
Drug: Oxaliplatin
IV infusion every second week for 8 weeks.
Other Names:
|
| Experimental: MOFOX / Bevacizumab Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab |
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
Drug: Oxaliplatin
IV infusion every second week for 8 weeks.
Other Names:
Drug: Bevacizumab
IV infusion every second week for 8 weeks.
Other Names:
|
| Experimental: MOFIRI Modufolin in combination with 5-Fluorouracil and Irinotecan |
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
Drug: Irinotecan
IV infusion every second week for 8 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Advanced metastatic colorectal (Stage IV) cancer verified by biopsy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Odense University Hospital | Odense | Denmark | ||
| 2 | 251 General Airforce Hospital | Athens | Greece | ||
| 3 | Medical School University of Athens, Aretaieio Hospital | Athens | Greece | ||
| 4 | Metropolitan General Hospital | Athens | Greece | ||
| 5 | University Genral Hospital Attikon | Athens | Greece | ||
| 6 | University General Hospital of Heraklion | Iráklion | Greece | ||
| 7 | Oslo University Hospital - Radiumhospitalet | Oslo | Norway | ||
| 8 | Oslo University Hospital - Ullevål | Oslo | Norway | ||
| 9 | Sahlgrenska University Hospital | Göteborg | Sweden | 461 85 | |
| 10 | Skaraborg hospital | Skövde | Sweden |
Sponsors and Collaborators
- Isofol Medical AB
Investigators
- Principal Investigator: Göran Carlsson, MD, Sahlgrenska University Hospital, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISO-CC-005
- 2014-001862-84