Advanced Metastatic (Stage IV) Colorectal Cancer Clinical Trial
Official title:
A Double Blinded Randomised Three Armed Phase II Trial of PledOx in Two Different Doses in Combination With FOLFOX6 Compared to Placebo + FOLFOX6 in Patients With Advanced Metastatic Colorectal (Stage IV) Cancer
The present trial is designed to determine whether pre-treatment with PledOx lowers the
frequency and severity of side effects from FOLFOX6 administration in patients with
metastatic colorectal cancer.
The efficacy of PledOx will be assessed when added to FOLFOX6 chemotherapy as first line
treatment of metastatic colorectal cancer.
This study was performed in multiple parts/phases. Part 1 was an open dose-escalation study
with the doses 2, 5 and 10 micromol/kg of calmangafodipir. No study outcomes were planned for
this part. In part 2a, participants randomly received either Placebo, 2 or 10 micromol/kg of
calmangafodipir. In part 2b, participants randomly received either Placebo, 2 or 5
micromol/kg of calmangafodipir. The overall intent of the study was to compare the effect of
antioxidant agent PledOx against placebo in one of three different doses/combinations (2
micromol/kg, 5/10 micromol/kg, 2/5/10 micromol/kg vs. placebo, in the first 8 cycles of
FOLFOX6 treatment
Globally, nearly 800 000 colorectal cancers are believed to occur annually. Approximately
about half of the patients with colorectal cancer develop metastatic disease. These patients
are often offered chemotherapy with the FOLFOX6 regimen (FOL = FOLic acid; F = Fluorouracil
(5-FU); OX = OXaliplatin) The use of FOLFOX6 is, however, hampered by a high incidence and
severity of adverse reactions.
In the current trial patients will receive the antioxidant agent PledOx in one of two
different doses, or placebo, in the first 8 cycles of FOLFOX6 treatment.
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