Colorectal Cancer Clinical Trial
Official title:
Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study
RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin
for cancer may help doctors learn more about changes that occur in DNA and identify
biomarkers related to neurotoxicity.
PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients
with colorectal cancer receiving oxaliplatin.
OBJECTIVES:
Primary
- Correlate predictive genetic, proteomic, and/or neurotrophic markers with neurological
manifestations related to the administration of oxaliplatin in patients with colorectal
carcinoma.
Secondary
- 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
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