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| ID | Type | Description | Link |
|---|---|---|---|
| CPP-NEUROTOXALI | |||
| CPP-CPP340 | |||
| INCA-RECF0453 | |||
| EUDRACT-2007-001287-75 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX regimen | Drug | |||
| fluorouracil | Drug | |||
| leucovorin calcium | Drug | |||
| oxaliplatin | Drug | |||
| gene expression analysis | Genetic | |||
| protein expression analysis | Genetic | |||
| proteomic profiling | Genetic | |||
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Erick Gamelin, MD | Institut Cancerologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Recruiting | Angers | 49036 | France |
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| laboratory biomarker analysis |
| Other |
| pharmacogenomic studies | Other |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D020869 | Gene Expression Profiling |
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
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