Status:
COMPLETED
Protective Effect of Mangafodipir Against Oxaliplatin Neurotoxicity
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Neurotoxic Disorders
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Detailed Description
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00727922
Start Date
June 1 2008
End Date
April 1 2011
Last Update
November 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cochin
Paris, France, 75014