Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT00049660
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2002-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], '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': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2002-11-12', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '17976988', 'type': 'RESULT', 'citation': 'Pajk B, Cufer T, Canney P, Ellis P, Cameron D, Blot E, Vermorken J, Coleman R, Marreaud S, Bogaerts J, Basaran G, Piccart M. Anti-tumor activity of capecitabine and vinorelbine in patients with anthracycline- and taxane-pretreated metastatic breast cancer: findings from the EORTC 10001 randomized phase II trial. Breast. 2008 Apr;17(2):180-5. doi: 10.1016/j.breast.2007.09.002. Epub 2007 Oct 31.'}, {'pmid': '34037241', 'type': 'DERIVED', 'citation': 'Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer.\n\nPURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy.', 'detailedDescription': 'OBJECTIVES: Phase II Study:\n\n* Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine.\n* Compare the duration of response in patients treated with these drugs.\n\nPhase III Study:\n\n* Compare overall and progression-free survival in patients treated with these drugs.\n* Compare time to treatment failure in patients treated with these drugs.\n* Compare overall safety of these drugs in these patients.\n* Compare quality of life and clinical benefit response in patients treated with these drugs.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and taxane resistance (refractory vs resistant vs sensitive).\n\n* Phase II: Patients are randomized to 1 of 2 treatment arms.\n\n * Arm I: Patients receive vinorelbine IV on days 1 and 8. Courses repeat every 21 days.\n * Arm II: Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days.\n\nIn both arms, treatment continues in the absence of progression or unacceptable toxicity.\n\nIf sufficient response rate is determined in phase II, the phase III study is initiated.\n\n* Phase III: Patients are randomized and receive treatment as in phase II. Quality of life is assessed prior to randomization, at weeks 3, 6, 9, 18, 24, and 30, and then every 12 weeks until disease progression.\n\nClinical benefit response is assessed daily while patient is on study.\n\nPatients are followed every 6 weeks until disease progression and then every 12 weeks thereafter.\n\nPROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for phase II of this study and a total of 406-452 patients (203-226 per treatment arm) will be accrued for phase III of this study within 18.5 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n* Metastatic disease\n* Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting\n\n * Taxane-resistant disease allowed regardless of duration of prior therapy NOTE: Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane\n * Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE: Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane\n* Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines\n* At least one unidimensionally measurable lesion (phase II study)\n* No CNS metastases\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin no greater than 1.25 times upper limit of normal (ULN)\n* Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)\n\nRenal\n\n* Creatinine clearance greater than 50 mL/min\n\nCardiovascular\n\n* No symptomatic ventricular arrhythmias\n* No clinically significant congestive heart failure\n* No clinical or ECG evidence of myocardial infarction within the past 12 months\n* No significant coronary artery disease\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix\n* No known or prior sensitivity to fluoropyrimidines, including fluorouracil\n* No pre-existing grade 2 or greater neurotoxicity\n* No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug\n* No psychological, familial, sociological, or geographical condition that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent biologic therapy\n\nChemotherapy\n\n* See Disease Characteristics\n* No more than 2 prior chemotherapy lines for metastatic disease\n* No prior capecitabine, vinca alkaloids, or continuous fluorouracil\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Prior hormonal therapy allowed\n* No concurrent hormonal therapy\n\nRadiotherapy\n\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* Bisphosphonate therapy for treatment and prevention of bony metastases allowed if initiated prior to study\n* No other concurrent investigational treatment\n* No concurrent brivudine with capecitabine'}, 'identificationModule': {'nctId': 'NCT00049660', 'briefTitle': 'Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'EORTC-10001-160010'}, 'secondaryIdInfos': [{'id': 'EORTC-10001'}, {'id': 'EORTC-16001O'}, {'id': 'IDBBC-EORTC-10001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'capecitabine', 'type': 'DRUG'}, {'name': 'vinorelbine tartrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Network Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', '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': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint-Augustinus', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '90471', 'city': 'Nurberg', 'country': 'Germany', 'facility': 'Klinikum Nuernberg - Klinikum Sued'}, {'zip': 'Sl-1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology - Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': 'S1O 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson Oncology Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Western Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Martine J. Piccart-Gebhart, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jules Bordet Institute'}, {'name': 'Chris Twelves, MD, BMedSci, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}