Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study
18 Years
N/A
Both
Chemotherapeutic Agent Toxicity, Colorectal Cancer, Neurotoxicity
Trial Information
Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
Safety Issue:
No
Principal Investigator
Erick Gamelin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
ICO Paul Papin
Authority:
Unspecified
Study ID:
CDR0000633477
NCT ID:
NCT00884767
Start Date:
September 2007
Completion Date:
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Colorectal Cancer
- Neurotoxicity
- 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
- Colorectal Neoplasms
- Neurotoxicity Syndromes
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