Chemotherapeutic Agent Toxicity, Colorectal Cancer, Neurotoxicity
Conditions
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
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.
Interventions
DRUGFOLFOX regimen
DRUGfluorouracil
DRUGleucovorin calcium
DRUGoxaliplatin
GENETICgene expression analysis
GENETICprotein expression analysis
GENETICproteomic profiling
OTHERlaboratory biomarker analysis
OTHERpharmacogenomic studies
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity | — |
Countries
France
Outcome results
None listed