Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00053820
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2003-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 670}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2003-02-05', 'studyFirstSubmitQcDate': '2003-02-05', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival'}], 'secondaryOutcomes': [{'measure': 'Time to progression as measured by RECIST criteria'}, {'measure': 'Comparison of toxicity levels (Grade III and IV)'}, {'measure': 'Comparison of quality of life before, during, after completion of study treatment'}, {'measure': 'Impact of the treatment regimens on health economics'}]}, 'conditionsModule': {'keywords': ['stage IV renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'referencesModule': {'references': [{'pmid': '20153039', 'type': 'RESULT', 'citation': 'Gore ME, Griffin CL, Hancock B, Patel PM, Pyle L, Aitchison M, James N, Oliver RT, Mardiak J, Hussain T, Sylvester R, Parmar MK, Royston P, Mulders PF. Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin-2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04/EORTC GU 30012): an open-label randomised trial. Lancet. 2010 Feb 20;375(9715):641-8. doi: 10.1016/S0140-6736(09)61921-8. Epub 2010 Feb 10.'}, {'type': 'RESULT', 'citation': 'Gore ME: Interferon-α (IFN), interleukin-2 (IL2) and 5-fluorouracil (5FU) vs IFN alone in patients with metastatic renal cell carcinoma (mRCC): results of the randomised MRC/EORTC RE04 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-5039, 2008.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer.", 'detailedDescription': 'OBJECTIVES:\n\n* Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil.\n* Compare the toxicity of these regimens in these patients.\n* Assess the quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I (Interferon alfa monotherapy): Patients receive interferon alfa subcutaneously (SC) on days 1, 3, and 5. Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity.\n* Arm II (Interferon alfa, interleukin-2, and fluorouracil combination therapy): Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1, 3, and 5 of weeks 2, 3, 5, 6, 7, and 8. Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1, 3, and 5 of weeks 2 and 3. Patients then receive fluorouracil IV on day 1 of weeks 5-8. Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months.\n\nPatients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed renal cell carcinoma\n\n * Advanced metastatic disease that requires treatment\n* Measurable disease (single bone lesions not included)\n* No brain metastasis\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 81\n\nPerformance status\n\n* WHO 0-1\n\nLife expectancy\n\n* More than 12 weeks\n\nHematopoietic\n\n* WBC greater than 3,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin greater than 10 g/dL\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No myocardial infarction within the past 6 months\n* No unstable angina pectoris\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for at least 6 months after study participation\n* No other concurrent disease or prior malignancy that would preclude study treatments or comparisons\n* No concurrent active infection requiring antibiotics\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior biologic therapy\n\nChemotherapy\n\n* No prior chemotherapy\n\nEndocrine therapy\n\n* No prior endocrine therapy\n* No concurrent corticosteroids\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy\n\nSurgery\n\n* Prior resection of the primary tumor recommended but not required\n* No prior major organ allografts'}, 'identificationModule': {'nctId': 'NCT00053820', 'briefTitle': 'Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000269480'}, 'secondaryIdInfos': [{'id': 'MRC-RE04'}, {'id': 'EORTC-30012'}, {'id': 'EU-20231'}, {'id': 'ISRCTN46518965'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aldesleukin', 'type': 'BIOLOGICAL'}, {'name': 'recombinant interferon alfa', 'type': 'BIOLOGICAL'}, {'name': 'fluorouracil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze Lieve Vrouw Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Academisch Ziekenhuis der Vrije Universiteit Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'D-34125', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Klinikum Kassel', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '2300 CA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum St. Radboud - Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3000 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'University Medical Center Rotterdam at Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3015 GJ', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': "Erasmus MC - Sophia Children's Hospital", 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '833 10', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'National Cancer Institute - Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'Martin E. Gore, MD', 'affiliation': 'Royal Marsden NHS Foundation Trust'}, {'name': 'Peter F.A. Mulders, MD, PhD', 'affiliation': 'Universitair Medisch Centrum St. Radboud - Nijmegen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}]}}}