Protective Effect of Mangafodipir Against Oxaliplatin Neurotoxicity

NCT00727922 | Completed Phase 2 DMC

• 1 other identifier: P071203
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurotoxic Disorders; Cancer

Keywords

Neuropathy; Oxaliplatin; Mangafodipir

Outcome Measures

Primary Outcomes (1)

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

  every 15 days

Secondary Outcomes (2)

• Number of oxaliplatin administration

  every 15 days

• Progression free survival (time from inclusion to cancer progression)

  6 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Mangafodipir

Interventions

Mangafodipir DRUG

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. During 4 months (8 administrations).

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin

Paris, 75014, France

Location

Related Publications (1)

• Coriat R, Alexandre J, Nicco C, Quinquis L, Benoit E, Chereau C, Lemarechal H, Mir O, Borderie D, Treluyer JM, Weill B, Coste J, Goldwasser F, Batteux F. Treatment of oxaliplatin-induced peripheral neuropathy by intravenous mangafodipir. J Clin Invest. 2014 Jan;124(1):262-72. doi: 10.1172/JCI68730. Epub 2013 Dec 20.

  PMID: 24355920 RESULT

MeSH Terms

Conditions

Neurotoxicity Syndromes; Neoplasms

Interventions

N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Jerome Alexandre, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 4, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2011
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

FR (1)