Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 7:11 PM
Study NCT ID:
NCT00138060
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2005-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-19', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tumor response rate', 'timeFrame': 'during the treatment'}], 'secondaryOutcomes': [{'measure': 'toxicity', 'timeFrame': 'during the treatment'}, {'measure': 'pharmacokinetics', 'timeFrame': 'during the first administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['genotypic profile', 'metastatic colorectal cancer'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '11990381', 'type': 'BACKGROUND', 'citation': 'Iyer L, Das S, Janisch L, Wen M, Ramirez J, Karrison T, Fleming GF, Vokes EE, Schilsky RL, Ratain MJ. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J. 2002;2(1):43-7. doi: 10.1038/sj.tpj.6500072.'}]}, 'descriptionModule': {'briefSummary': 'This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration.\n\nThe results of this identification determine the chemotherapy type: high-dose irinotecan or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice\n* Ages between 18 and 85 years\n* Histologically confirmed colorectal cancer\n* No treatment for metastatic disease\n* No irinotecan previously administered\n* World Health Organization (WHO) performance status \\< 3\n* Laboratory values :\n\n * neutrophils \\> 1.5 x 10\\^9/L;\n * platelet count \\> 100 x 10\\^9/L;\n * serum creatinine \\< 130µmol/L;\n * serum bilirubin \\< 2 x upper limit of normal (ULN);\n * ASAT and ALAT \\< 2.5 x ULN;\n * alkaline phosphatase \\< 5 x ULN.\n* At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n\nExclusion Criteria:\n\n* History of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder.\n* Other concomitant anticancer therapy.\n* Pregnant or lactating women.\n* Women of childbearing potential unless using a reliable and appropriate contraceptive method.\n* Symptomatic cerebral or leptospiral metastasis.\n* Intestinal obstruction.\n* Uncontrolled seizures (diabetes, severe infection).\n* Clinically significant cardiac disease.\n* Central nervous system disorders or severe psychiatric disability.\n* Participation in any investigational study within 4 weeks.'}, 'identificationModule': {'nctId': 'NCT00138060', 'briefTitle': 'Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Recherche Clinique sur les Cancers et le Sang'}, 'officialTitle': "Protocole Evaluant Chez Des Patients Porteurs de Cancers Colorectaux Metastatiques l'Interet Des Determinants Genotypiques Pour l'Optimisation de l'Efficacite et de la Tolerance de la Chimiotherapie Par Irinotecan et 5-fluorouracile", 'orgStudyIdInfo': {'id': 'COLOGEN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'irinotecan', 'type': 'DRUG', 'description': '180 mg/m² or 260 mg/m² in 90 minutes every 15 days'}, {'name': '5 fluorouracil', 'type': 'DRUG', 'description': '400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Department of Oncology, CHU', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38100', 'city': 'Grenoble', 'country': 'France', 'facility': 'Department of Oncology, IPC', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Department of Gastroenterology, CHLS', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Department of Oncology - CHLS', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '42271', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Department of Oncology, ICL', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Gilles Freyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology, CHLS, 69310 Pierre Benite, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherche Clinique sur les Cancers et le Sang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Gilles Freyer', 'oldOrganization': 'IRCCSang'}}}}