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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
Information provided by:
National Cancer Institute (NCI)

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.

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

Detailed Description:



  • 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
Allocation: Non-Randomized
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Primary Outcome Measures :
  1. Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed colorectal cancer
  • Requires treatment with oxaliplatin (as part of a FOLFOX regimen)
  • No brain metastases or symptomatic meningitis


  • WHO performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Total bilirubin ≤ 2 times upper limit of normal (ULN)
  • Transaminases ≤ 3 times ULN
  • Alkaline phosphatase ≤ 5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior or concurrent clinical neuropathy (regardless of the etiology)
  • No dihydropyrimidine dehydrogenase deficiency
  • No psychiatric illness that would preclude comprehension of the study or of the informed consent
  • No other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection
  • No psychological, social, familial, or geographical reason that would preclude study follow-up
  • Other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes


  • See Disease Characteristics
  • Prior chemotherapy allowed (except for platinum derivatives or taxanes)

Information from the National Library of Medicine

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    e.gamelin@unimedia.fr   
Sponsors and Collaborators
ICO Paul Papin
Principal Investigator: Erick Gamelin, MD ICO Paul Papin

ClinicalTrials.gov Identifier: NCT00884767     History of Changes
Other Study ID Numbers: CDR0000633477
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
chemotherapeutic agent toxicity
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
recurrent rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nervous System Diseases
Chemically-Induced Disorders
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents