By Andy Giusti, Ph. D, C3 Research Program Manager
A phase IV clinical trial designed to test if calcium/magnesium infusions lessened neuropathy when administered with Eloxatin (oxaliplatin) as part of the common FOLFOX+Avastin chemotherapeutic regimen has been closed. The manufacturer of Eloxatin, Sanofi-Aventis has stopped the trial after an interim analysis indicated that the use of calcium/magnesium could reduce the effectiveness of this chemotherapy treatment.
This study compared the use of calcium/magnesium infusions vs. placebo in previously untreated colorectal cancer patients receiving FOLFOX+ Avastin. The objective of the study was to determine if the addition of calcium/magnesium would reduce the severity or incidence of neuropathy, a commonly observed side effect in patients that are receiving Eloxatin as part of their chemotherapy treatments.
The trial was stopped while Sanofi-Aventis performs a more complete analysis of their data. It should be noted that this was not a safety issue with Eloxatin, but rather an issue of reduced efficacy when using calcium/magnesium in an attempt to lessen the side effects of Eloxatin treatment.
Until this analysis is made available, patients should carefully weigh the supposed benefit of decreased neuropathy that may be obtained when using calcium/magnesium, with the potentially more serious prospect of reduced effectiveness of their chemotherapy treatment.
Disclosure: C3 has accepted funding for projects and educational programs from Sanofi-Aventis in the form of charitable donations. C3 has ultimate authority over website content.