Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00884767
Status:
UNKNOWN
Last Update Posted:
2009-07-08
First Post:
2009-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C410216', 'term': 'Folfox protocol'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D000071185', 'term': 'Pharmacogenomic Testing'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2009-07-07', 'studyFirstSubmitDate': '2009-04-18', 'studyFirstSubmitQcDate': '2009-04-18', 'lastUpdatePostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity'}]}, 'conditionsModule': {'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'], 'conditions': ['Chemotherapeutic Agent Toxicity', 'Colorectal Cancer', 'Neurotoxicity']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Correlate predictive genetic, proteomic, and/or neurotrophic markers with neurological manifestations related to the administration of oxaliplatin in patients with colorectal carcinoma.\n\nSecondary\n\n* Differentiate between risk factors predictive of acute and chronic neurotoxicity.\n* Establish a possible relationship between acute and chronic neurotoxicity.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oxaliplatin every 2 weeks as part of a FOLFOX chemotherapy regimen.\n\nBlood 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed colorectal cancer\n* Requires treatment with oxaliplatin (as part of a FOLFOX regimen)\n* No brain metastases or symptomatic meningitis\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-2\n* Life expectancy \\> 3 months\n* ANC ≥ 1 x 10\\^9/L\n* Platelet count ≥ 100 x 10\\^9/L\n* Total bilirubin ≤ 2 times upper limit of normal (ULN)\n* Transaminases ≤ 3 times ULN\n* Alkaline phosphatase ≤ 5 times ULN\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No prior or concurrent clinical neuropathy (regardless of the etiology)\n* No dihydropyrimidine dehydrogenase deficiency\n* No psychiatric illness that would preclude comprehension of the study or of the informed consent\n* No other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection\n* No psychological, social, familial, or geographical reason that would preclude study follow-up\n* Other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Prior chemotherapy allowed (except for platinum derivatives or taxanes)'}, 'identificationModule': {'nctId': 'NCT00884767', 'briefTitle': 'Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study', 'orgStudyIdInfo': {'id': 'CDR0000633477'}, 'secondaryIdInfos': [{'id': 'CPP-NEUROTOXALI'}, {'id': 'CPP-CPP340'}, {'id': 'INCA-RECF0453'}, {'id': 'EUDRACT-2007-001287-75'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'FOLFOX regimen', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}, {'name': 'oxaliplatin', 'type': 'DRUG'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'protein expression analysis', 'type': 'GENETIC'}, {'name': 'proteomic profiling', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'pharmacogenomic studies', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49036', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Erick Gamelin, MD', 'role': 'CONTACT', 'email': 'e.gamelin@unimedia.fr', 'phone': '33-2-4135-2700'}], 'facility': 'Centre Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Erick Gamelin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut Cancerologie de l'Ouest"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}}}}