Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00311467
Status:
TERMINATED
Last Update Posted:
2012-05-16
First Post:
2006-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D007378', 'term': 'Interleukins'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'whyStopped': 'no patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2006-04-05', 'studyFirstSubmitQcDate': '2006-04-05', 'lastUpdatePostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary study objective is to investigate whether the addition of capecitabine to interferon-alpha-interleukin-2 based immunotherapy may improve progression free survival when compared to immunotherapy alone.'}], 'secondaryOutcomes': [{'measure': "The study's secondary objectives are to investigate differences in response rates, safety and survival."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['renal cell cancer'], 'conditions': ['Renal Cell Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cecog.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma.', 'detailedDescription': 'Treatment plan Group A\n\nPatients randomised to group A will receive treatment according to the following treatment schedule:\n\nGroup A: Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy\n\n* Week 1:Capecitabine / Interferon;\n* Week 2:Capecitabine / Interferon;\n* Week 3:REST PERIOD / Interleukin;\n* Week 4:Capecitabine / Interleukin;\n* Week 5:Capecitabine / REST PERIOD;\n* Week 6:REST PERIOD / Interferon;\n* Week 7:Capecitabine / Interferon;\n* Week 8:Capecitabine / Interleukin;\n* Week 9:REST PERIOD / Interleukin;\n* Week 10:Capecitabine / REST PERIOD;\n* Week 11:Capecitabine / Interferon;\n* Week 12:REST PERIOD / Interferon;\n* Week 13:Capecitabine / Interleukin;\n* Week 14:Capecitabine / Interleukin;\n\nDOSAGES AND ROUTES OF ADMINISTRATION:\n\nCapecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.\n\nInterferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.\n\nInterleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.\n\nGroup B\n\nPatients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.\n\nEfficacy evaluations will be performed every 14 weeks of treatment in both groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed renal cell carcinoma (primary tumour or biopsy/surgery of metastases)\n* Radiologically confirmed metastatic disease\n* Surgically removed primary tumour so feasible (nephrectomy or nephron-sparing surgery as indicated)\n* Karnofsky-Performance Status \\>70%\n* Age 19-75 years\n* Life expectancy of at least 3 months\n* Adequate bone marrow function (i.e. white blood cell count above 3000/μL, platelet count above 75 000 /μL, hemoglobin above 9 mg/dl)\n* Adequate organ function (i.e. serum creatinine, bilirubin and AST below 1.25 x the upper limit of the institutions' normal range)\n* Negative pregnancy test for female patients\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\<19 or \\>75 years\n* Karnofsky-Performance Status \\< 70%\n* Untreated or uncontrolled brain metastases\n* Second neoplasia\n* Primary tumour surgically removable\n* Solitary, surgically removable metastases\n* Major concomitant diseases of the cardiovascular, respiratory or renal systems, as well as active systemic infections\n* Severe renal disease or liver insufficiency or myeloid dysfunction (including patients with a history of a disease that is likely to interfere with the metabolism or excretion of the test medication)\n* Other less common diseases as peptic ulcer disease, inflammatory bowel disease, autoimmune disease (severe known psoriasis, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)\n* Drug addiction (including excessive alcohol consumption) within 1 year prior to study start.\n* History of other conditions consistent with decompensated liver disease or other evidence of bleeding form esophageal varices.\n* History of chronic hepatitis and immunsupressiva\n* Known HIV Infection\n* Evidence of allergy or hypersensitivity against recombinant Interferon alfa-2a or other components of preparation.\n* History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.\n* Seizure disorders and /or compromised central nervous system function.\n* History of evidence of severe retinopathy\n* Patient unwilling or unable to give informed consent\n* Pregnancy or breastfeeding"}, 'identificationModule': {'nctId': 'NCT00311467', 'briefTitle': 'Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Central European Cooperative Oncology Group'}, 'officialTitle': 'Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial', 'orgStudyIdInfo': {'id': 'CECOG RCC 1.3.001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine and Interferon', 'description': 'Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy', 'interventionNames': ['Drug: Capecitabine, Interferon, Interleukin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interferon', 'description': 'Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.\n\nEfficacy evaluations will be performed every 14 weeks of treatment in both groups', 'interventionNames': ['Drug: Capecitabine, Interferon, Interleukin']}], 'interventions': [{'name': 'Capecitabine, Interferon, Interleukin', 'type': 'DRUG', 'description': 'Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.\n\nInterferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.\n\nInterleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.\n\nGroup B\n\nPatients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.\n\nEfficacy evaluations will be performed every 14 weeks of treatment in both groups', 'armGroupLabels': ['Capecitabine and Interferon', 'Interferon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Univ. Klinik f. Innere Medizin, Abt. Onkologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Manuela Schmidinger, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ. Klinik f. Innere Med. I, Abt. Onkologie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central European Cooperative Oncology Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}