Back to resultsBiomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin
Primary Purpose
Chemotherapeutic Agent Toxicity, Colorectal Cancer, Neurotoxicity
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFOX regimen
fluorouracil
leucovorin calcium
oxaliplatin
gene expression analysis
protein expression analysis
proteomic profiling
laboratory biomarker analysis
pharmacogenomic studies
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapeutic Agent Toxicity focused on measuring 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
Eligibility 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)
Sites / Locations
- Centre Paul PapinRecruiting
Outcomes
Primary Outcome Measures
Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
Secondary Outcome Measures
Full Information
NCT ID
NCT00884767
First Posted
April 18, 2009
Last Updated
July 7, 2009
Sponsor
Institut Cancerologie de l'Ouest
1. Study Identification
Unique Protocol Identification Number
NCT00884767
Brief Title
Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin
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 Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Cancerologie de l'Ouest
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapeutic Agent Toxicity, Colorectal Cancer, Neurotoxicity
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Genetic
Intervention Name(s)
proteomic profiling
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacogenomic studies
Primary Outcome Measure Information:
Title
Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erick Gamelin, MD
Organizational Affiliation
Institut Cancerologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erick Gamelin, MD
Phone
33-2-4135-2700
Email
e.gamelin@unimedia.fr
12. IPD Sharing Statement
Learn more about this trial
Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin
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