Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin
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|ClinicalTrials.gov Identifier: NCT00884767|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 21, 2009
Last Update Posted : July 8, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapeutic Agent Toxicity Colorectal Cancer Neurotoxicity||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||Phase 2|
- Correlate predictive genetic, proteomic, and/or neurotrophic markers with neurological manifestations related to the administration of oxaliplatin in patients with colorectal carcinoma.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|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 Start Date :||September 2007|
|Estimated Primary Completion Date :||August 2009|
- Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884767
|Centre Paul Papin||Recruiting|
|Angers, France, 49036|
|Contact: Erick Gamelin, MD 33-2-4135-2700 firstname.lastname@example.org|
|Principal Investigator:||Erick Gamelin, MD||ICO Paul Papin|