Spots Global Cancer Trial Database for Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

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Trial Identification

Brief Title: Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

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

Study ID: NCT00884767

Conditions

Chemotherapeutic Agent Toxicity

Colorectal Cancer

Neurotoxicity

Interventions

gene expression analysis

protein expression analysis

proteomic profiling

laboratory biomarker analysis

pharmacogenomic studies

Study Description

Brief Summary: 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.

Detailed Description: 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.