Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT00075595
Status:
UNKNOWN
Last Update Posted:
2009-01-06
First Post:
2004-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable 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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2009-01-03', 'studyFirstSubmitDate': '2004-01-09', 'studyFirstSubmitQcDate': '2004-01-11', 'lastUpdatePostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Time to death from progression'}], 'secondaryOutcomes': [{'measure': 'Objective response'}, {'measure': 'Stabilization rate'}, {'measure': 'Time to treatment failure'}, {'measure': 'Duration of response'}, {'measure': 'Overall survival rate'}, {'measure': 'Incidence of grade 3 or 4 toxicity'}]}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV rectal cancer', 'recurrent colon cancer', 'recurrent rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan.\n\nSecondary\n\n* Determine the objective response and stabilization rate in patients treated with this regimen.\n* Determine the time to treatment failure in patients treated with this regimen.\n* Determine the duration of response in patients treated with this regimen.\n* Determine overall survival rate in patients treated with this regimen.\n* Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed colorectal adenocarcinoma\n\n * Metastatic, unresectable disease\n* Meets 1 of the following criteria:\n\n * At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan\n * Evaluable disease\n * Evidence of disease (e.g., ascites or bone metastases) by imaging techniques\n* Progressive disease as defined by 1 of the following criteria:\n\n * Progressive disease while receiving first-line chemotherapy\n * Recurrent disease within 6 months after completing adjuvant chemotherapy\n* No symptomatic brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 80\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin \\< 1.5 times upper limit of normal (ULN)\n* Alkaline phosphatase \\< 3 times ULN\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No uncontrolled angina\n* No myocardial infarction within the past 6 months\n\nGastrointestinal\n\n* No chronic diarrhea grade 2 or greater\n* No unresolved fully or partially obstructed intestine\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other underlying disease or medical condition that would preclude study participation\n* No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix\n* No psychological, social, familial, or geographical condition that would preclude study follow-up\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n* No prior irinotecan\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy\n\nSurgery\n\n* At least 3 weeks since prior surgery\n\nOther\n\n* No other concurrent clinical trial participation'}, 'identificationModule': {'nctId': 'NCT00075595', 'briefTitle': 'Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer', 'orgStudyIdInfo': {'id': 'CDR0000347378'}, 'secondaryIdInfos': [{'id': 'FRE-GERCOR-FOLFIRI3-C00-2'}, {'id': 'EU-20333'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'FOLFIRI regimen', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Hopital Drevon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospital Universitaire Hop Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Clinique Saint Jean', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13008', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': 'Intercommunal Hospital', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': 'F-92202', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'American Hospital of Paris', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Europeen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat - Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'Clinique Ste - Marie', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': 'F-51100', 'city': 'Reims', 'country': 'France', 'facility': 'Polyclinique De Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': 'F-22015', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Clinique Armoricaine De Radiologie', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '67010', 'city': 'Strasbourg', 'country': 'France', 'facility': "Clinique de l'Orangerie", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Centre Medico-Chirurgical Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'May Mabro, MD', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GERCOR - Multidisciplinary Oncology Cooperative Group', 'class': 'OTHER'}}}}