NCT00884767

Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapeutic Agent Toxicity
• Colorectal Cancer
• Neurotoxicity

Interventions

Type	Name	Description
DRUG	FOLFOX regimen
DRUG	fluorouracil
DRUG	leucovorin calcium
DRUG	oxaliplatin
GENETIC	gene expression analysis
GENETIC	protein expression analysis
GENETIC	proteomic profiling
OTHER	laboratory biomarker analysis
OTHER	pharmacogenomic studies

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-08-01
• First posted: 2009-04-21
• Last updated: 2009-07-08

Locations

1 site across 1 country: France