A Local Feasibility Study on Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Patients Operated Upon Colon Cancer Stage Dukes' C
Mangafodipir, manganese (Mn) dipyridoxyl diphosphate, is a catalytic antioxidant and iron
chelator recently (2006) suggested for cancer treatment in an Editorial in Journal of the
National Cancer Institute. Preclinical research has shown that mangafodipir protects normal
tissues without loss of anti-tumour activity during chemotherapy. Other advantages are that
mangafodipir is already approved for use in patients as a contrast agent for magnetic
resonance imaging (MRI) of liver, and that the experience for more than a decade reveals
high safety with mainly minor and tolerable side-effects.
The present study will include 14 patients who will be followed throughout 3 treatment
cycles. Each cycle will be preceded by infusion of mangafodipir or placebo in two groups,
each consisting of 7 patients. The primary endpoints will be the most frequent manifestation
of FOLFOX6, namely neutropenia and neurosensory toxicity. The secondary endpoints will be
the frequency and severity of other FOLFOX6-related adverse events and quality of life.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Neutropenia
Before and after completion of one, two and/or three FOLFOX6-cycles
No
Ursula Falkmer, MD, PhD
Principal Investigator
Länssjukhuset Ryhov
Sweden: Medical Products Agency
PP 01-07
NCT00671996
June 2008
April 2010
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