Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-30 @ 12:42 AM
Study NCT ID:
NCT00006468
Status:
UNKNOWN
Last Update Posted:
2009-01-13
First Post:
2000-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Two Combination Chemotherapy Regimens 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': 'C410216', 'term': 'Folfox protocol'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'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': '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-12', 'lastUpdateSubmitDate': '2009-01-10', 'studyFirstSubmitDate': '2000-11-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, '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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for metastatic colorectal cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of intermittent high-dose oxaliplatin in combination with a simplified bimonthly regimen of leucovorin calcium (LV) and fluorouracil (5-FU) vs standard dose oxaliplatin in combination with the standard bimonthly regimen of LV and 5-FU in patients with metastatic colorectal cancer.\n* Determine the time to treatment failure, tolerance, response rate, and overall survival in patients treated with these 2 regimens.\n* Compare quality of life of these patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to treatment center, performance status (0-1 vs 2), and number of metastatic sites (1 vs more than 1). Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive oxaliplatin IV over 2 hours on day 1, and leucovorin calcium IV over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2.\n* Arm II: Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours followed by 5-FU IV over 46 hours beginning on day 1 for courses 1-6 and 19-24. For courses 7-18, patients receive leucovorin calcium IV followed by 5-FU IV as above beginning on day 1.\n\nCourses repeat every 14 days in both arms in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, after courses 4 and 6, and every 6 courses thereafter.\n\nPatients are followed monthly for 3 months and then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 460 patients (230 per treatment arm) 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 unresectable metastatic adenocarcinoma of the colon or rectum\n* Bidimensionally measurable or evaluable disease outside previously irradiated area\n\n * No bone metastasis as target lesion\n * At least 1 cm if spiral CT scan OR\n * At least 2 cm if conventional CT scan\n* No CNS metastasis\n* No symptomatic ascites or pleural effusion that is not evacuated\n* No total or partial bowel obstruction\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 80\n\nPerformance status:\n\n* ECOG 0-2\n* WHO 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Alkaline phosphatase less than 5 times upper limit of normal (ULN)\n\nRenal:\n\n* Creatinine less than 3 times ULN\n* No uncontrolled hypercalcemia\n\nCardiovascular:\n\n* No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias\n\nOther:\n\n* No peripheral sensory neuropathy\n* No prior significant neurologic or psychiatric disorders\n* No other malignancy within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma\n* No active infection\n* No other concurrent serious disease\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior immunotherapy for metastatic disease\n\nChemotherapy:\n\n* Prior adjuvant chemotherapy allowed, provided progression-free interval of more than 6 months since end of last course\n* No prior oxaliplatin or irinotecan\n* No prior chemotherapy for metastatic disease\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No concurrent radiotherapy\n\nSurgery:\n\n* Concurrent surgery allowed\n\nOther:\n\n* At least 30 days since other prior investigational drugs\n* No other concurrent investigational treatment\n* No other concurrent antitumoral treatment'}, 'identificationModule': {'nctId': 'NCT00006468', 'briefTitle': 'Comparing Two Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.', 'orgStudyIdInfo': {'id': 'CDR0000068282'}, 'secondaryIdInfos': [{'id': 'FRE-GERCOR-OPTIMOX-2000'}, {'id': 'EU-20034'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'FOLFOX regimen', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}, {'name': 'oxaliplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Aimery de Gramont, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Saint Antoine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GERCOR - Multidisciplinary Oncology Cooperative Group', 'class': 'OTHER'}}}}