Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00884767
First received: April 18, 2009
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity [ Designated as safety issue: No ]

Estimated Enrollment: 206
Study Start Date: September 2007
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884767

Locations
France
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
Investigators
Principal Investigator: Erick Gamelin, MD ICO Paul Papin
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00884767     History of Changes
Other Study ID Numbers: CDR0000633477, CPP-NEUROTOXALI, CPP-CPP340, INCA-RECF0453, EUDRACT-2007-001287-75
Study First Received: April 18, 2009
Last Updated: July 7, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
neurotoxicity
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
Chemically-Induced Disorders
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Poisoning
Rectal Diseases
Fluorouracil
Levoleucovorin
Oxaliplatin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014