Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

July 7, 2009 updated by: Institut Cancerologie de l'Ouest

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49036
        • Recruiting
        • Centre Paul Papin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Erick Gamelin, MD, Institut Cancerologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

April 18, 2009

First Submitted That Met QC Criteria

April 18, 2009

First Posted (Estimate)

April 21, 2009

Study Record Updates

Last Update Posted (Estimate)

July 8, 2009

Last Update Submitted That Met QC Criteria

July 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000633477
  • CPP-NEUROTOXALI
  • CPP-CPP340
  • INCA-RECF0453
  • EUDRACT-2007-001287-75

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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