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Evaluation of Mangafodipir Protective Activity Against Oxaliplatin Neurotoxicity

Phase 2
18 Years
Not Enrolling
Neurotoxic Disorders, Cancer

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Trial Information

Evaluation of Mangafodipir Protective Activity Against Oxaliplatin Neurotoxicity

Phase 2 study aiming to assess the protective effect of mangafodipir against the
oxaliplatine neuropathy.Population: Cancer patient who have a mild (grade 2) oxaliplatin
neuropathy and in whom the continuation of oxaliplatin for at least 4 infusions is desirable
will be include, whatever the location of the primitive tumor and the use of others
anticancer agents.Treatment: Mangafodipir (0.5 ml/kg) is administered as a 30 minutes
infusion just after each administration of oxaliplatin. The oxaliplatin dose (85 to 100
mg/m²) and the length of the infusion (2 hours) are the same that before the inclusion and
modifications are not authorized during all the study participation. Primary objective:
Neuropathy are clinically evaluated according to NCI-CTC criteria before each mangafodipir
and oxaliplatin and thereafter one month after the last infusion. The primary criteria is
the worst grade of oxaliplatin neuropathy experienced by each patient. The improvement of
neuropathy is defined as a decrease by at least one grade of the severity of the neuropathy
for at least 2 months.

Hypothesis: at least 50% of patients will experience an improvement or a stabilization of
the oxaliplatin neuropathy while receiving the mangafodipir - oxaliplatin
association.Treatment discontinuation: the treatment will be stopped if the neuropathy
worsened by at least one grade, in case of tumor progression, intolerable toxicity, and
patient wish.

Number of patients: it will be determined according to a simplified Gehan procedure: The
inclusions will be stopped if no objective response (neuropathy improvement) is observed
among the first 9 evaluable patients. If at least one response is observed, 16 more
evaluable patients will be include. The total number of patients will be between 9 and 30
patients, including non evaluable patients.

Pharmacokinetic: Serum and intra- erythrocytes manganese concentration will be evaluated
before each mangafodipir infusion in order to detect accumulation Pharmacodynamic: plasmatic
total antioxidant activity, superoxide dismutase activity and lipid peroxidation will be
assessed at the first cycle: before and after the administration of oxaliplatin and just
after the perfusion of mangafodipir.

Inclusion Criteria:

- NCI CTC grade 2 or more neuropathy induced by oxaliplatine

- At least 18 years old

- ECOG PS: 2 or less

- Life expectancy longer than 3 months

- Written informed consent

- Adequate hematologic, liver and renal functions

Exclusion Criteria:

- Known hypersensibility to oxaliplatine

- Cancer resistant to oxaliplatine

- Fertile woman or man not willing to use adequate contraception

- Pregnant or lactating women

- Vitamin B6 administration within 48h prior to mangafodipir administration

- Uncontrolled infection

- Treatment with any other investigational agent, or participation in another clinical
trial within 3 weeks prior to first administration of mangafodipir

- Evidence of any other disease or condition that contra-indicates the use of an
investigational drug

- No Social Security insurance

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal neuropathy severity (NCI-CTC score) established before each oxaliplatin injection

Outcome Time Frame:

every 15 days

Safety Issue:


Principal Investigator

Jerome Alexandre, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

June 2008

Completion Date:

April 2011

Related Keywords:

  • Neurotoxic Disorders
  • Cancer
  • Neuropathy
  • Oxaliplatin
  • Mangafodipir
  • Neurotoxicity Syndromes