Protective Effect of Mangafodipir Against Oxaliplatin Neurotoxicity

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Oxaliplatin is a major antitumor agent but its use is limited by potentially disabling neurotoxicity, characterized by a sensitive defect in the extremities.Mangafodipir is a MRI contrast agent with antioxidant properties. Our previous laboratory works showed that mangafodipir is able to prevent hematologic toxicity of several chemotherapy agents, including oxaliplatin and to increase their antitumor activity. Preliminary clinical data suggested that mangafodipir could prevent oxaliplatin neurotoxicity.The primary purpose of the present study is to assess the protective effect of mangafodipir in patients who have a already moderate oxaliplatin neuropathy and in whom the continuation of this treatment is desirable because of significant antitumor effect.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Edetic Acid; Oxaliplatin; Pyridoxal Phosphate

Criteria

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