Metastatic Colorectal Cancer Clinical Trial
Official title:
A Randomised Phase II Study Investigating Two Doses of Arfolitixorin Compared to Calciumfolinate Together With 5- Fluorouracil on TS Inhibition in Tumour and Adjacent Hepatic Tissue for Patients With Liver Metastases From Colorectal Cancer
A study that is blinded to the patient and the investigator where the combination of
Arfolitixorin + 5-FU is compared to Calciumfolinate + 5-FU. The patients will be randomised
and will receive the above described combination as IV bolus injections, peroperatively in
conjuction with collection of the first tissue sample.
A low dose (30 mg) and a high dose (120) mg of Arfolitixorin will be used in order to
investigate the relation between dose of Arfolitixorin and TS-inhibition.
Arfolitixorin ([6R] 5,10-methylenetetrahydrofolate) is a folate based biomodulator designed
to replace leucovorin. Arfolitixorin is the key active metabolite of leucovorin (LV) and does
in contrast to LV not require enzymatic metabolic activation. In clinical practice, LV is
administered in the form of Calciumfolinate. A hypothesis is therefore that patients which
are not capable of metabolizing LV could have a better antitumoral effect with Arfolitixorin
administration. The antitumoural effect could be measured as inhibition of the enzyme
thymidylate synthase, an enzyme essential for DNA synthesis.
Primary objective The primary objective is to compare the properties of Arfolitixorin and
Calciumfolinate together with 5-fluorouracil (5-FU) on thymidylate synthase (TS) (i.e.
measured as thymidylate synthase inhibition) in tumour and adjacent liver tissue in patients
with liver metastases from colorectal cancer receiving a peroperative intravenous
administration of Arfolitixorin or Calciumfolinate.
Secondary objectives To study safety in terms of adverse events and laboratory measurements;
haematology and clinical chemistry.
To explore differences in pharmacokinetics of folates and folate metabolites in plasma.
To study gene expression in tumour and adjacent hepatic tissue and its correlation to tissue
concentration.
To investigate the relation between the levels of deoxyuridine (dU) in plasma with the amount
of TS inhibition in tumour tissue, in order to evaluate dU as a surrogate marker for
TS-inhibition.
Study population:
Thirty adult patients with colorectal cancer and liver metastases, indicated for surgical
removal will be randomised.
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