Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study
- Correlate predictive genetic, proteomic, and/or neurotrophic markers with neurological
manifestations related to the administration of oxaliplatin in patients with colorectal
- Differentiate between risk factors predictive of acute and chronic neurotoxicity.
- Establish a possible relationship between acute and chronic neurotoxicity.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin every 2 weeks as part of a FOLFOX chemotherapy regimen.
Blood samples are collected 15 days prior to beginning chemotherapy, prior to each course of
chemotherapy, and at 1 month after completion of chemotherapy for pharmacogenetic and
laboratory biological studies. Patients with chronic neurotoxicity undergo additional blood
sample collection at 3, 6, 9, and 12 months after completion of chemotherapy. Samples are
analyzed for the detection of gene variants involved in the oxalate and fluorouracil
metabolic pathway; neurotrophic factors; proteomic analysis of plasma proteins and peptides;
and for biological testing of neurotoxicity.
Allocation: Non-Randomized, Primary Purpose: Treatment
Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
Erick Gamelin, MD
ICO Paul Papin