Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT00080951
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2004-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], '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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2004-04-07', 'studyFirstSubmitQcDate': '2004-04-07', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tumor response rate', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'time to progression', 'timeFrame': 'Up to 5 years'}, {'measure': 'overall survival', 'timeFrame': 'Up to 5 years'}, {'measure': 'time to treatment failure', 'timeFrame': 'Up to 5 years'}, {'measure': 'quality of life', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '17553200', 'type': 'RESULT', 'citation': 'McWilliams RR, Goetz MP, Morlan BW, Salim M, Rowland KM, Krook JE, Ames MM, Erlichman C. Phase II trial of oxaliplatin/irinotecan/5-fluorouracil/leucovorin for metastatic colorectal cancer. Clin Colorectal Cancer. 2007 May;6(7):516-21. doi: 10.3816/CCC.2007.n.017.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy as first-line therapy in treating patients who have metastatic colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the tumor response rate in patients with metastatic colorectal cancer treated with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line treatment.\n\nSecondary\n\n* Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n* Determine the quality of life of patients treated with this regimen.\n* Determine whether UGT1A1 polymorphism is related to toxicity (especially leukopenia, diarrhea, or neutropenia) or response in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, before each chemotherapy course, and at the end of treatment.\n\nPatients are followed every 3 months until 5 years after registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of colorectal adenocarcinoma\n\n * Metastatic disease\n* Not curable by surgery or amenable to radiotherapy with curative intent\n* Measurable disease\n\n * Patients with only lesions measuring ≥ 1 cm but \\< 2 cm must use spiral CT scan for pre- and post-treatment tumor assessments\n* No known CNS metastases or carcinomatous meningitis\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* AST ≤ 5 times upper limit of normal (ULN)\n* Bilirubin ≤ 0.5 mg/dL above ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN OR\n* Creatinine clearance ≥ 60 mL/min\n\nCardiovascular\n\n* No unstable angina\n* No symptomatic congestive heart failure\n* No serious uncontrolled cardiac arrhythmia\n\nPulmonary\n\n* No prior clinical diagnosis of interstitial lung disease\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active or uncontrolled infection\n* No other concurrent serious illness\n* No pre-existing paraesthesias/dysesthesias of ≥ grade 2 that would interfere with function\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent sargramostim (GM-CSF)\n\nChemotherapy\n\n* At least 6 months since prior adjuvant chemotherapy\n* No prior fluorouracil for advanced colorectal cancer\n* No prior adjuvant oxaliplatin\n* No prior adjuvant irinotecan\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy to \\> 25% of bone marrow\n\nSurgery\n\n* At least 4 weeks since prior major surgery'}, 'identificationModule': {'nctId': 'NCT00080951', 'briefTitle': 'Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'NCCTG-N0341'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02581', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}, {'id': 'CDR0000357571', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'irinotecan + oxaliplatin + leucovorin + fluorouracil', 'description': 'Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, before each chemotherapy course, and at the end of treatment.\n\nPatients are followed every 3 months until 5 years after registration.', 'interventionNames': ['Drug: fluorouracil', 'Drug: irinotecan hydrochloride', 'Drug: leucovorin calcium', 'Drug: oxaliplatin']}], 'interventions': [{'name': 'fluorouracil', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + oxaliplatin + leucovorin + fluorouracil']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + oxaliplatin + leucovorin + fluorouracil']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + oxaliplatin + leucovorin + fluorouracil']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + oxaliplatin + leucovorin + fluorouracil']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Charles Erlichman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}