Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT00201435
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-19', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to treatment failure'}, {'measure': 'Quality of life'}], 'secondaryOutcomes': [{'measure': 'Response rates'}, {'measure': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast', 'Cancer', 'Paclitaxel', 'Docetaxel', 'Qulaity of life'], 'conditions': ['Breast Neoplasm']}, 'descriptionModule': {'briefSummary': 'We want to compare Taxol given weekly with Taxotere given every 3 week both in comination with Xeloda. We are going to compare time to treatment failure and quality of life.', 'detailedDescription': 'Open labeled randomized multicentre phase II/III trial. It is intended to include patients who are not usually included into clinical trials because they are not having disease with measurable lesions. In breast cancer the bulk of patients with metastatic disease is presenting with bone metastases which is difficult to evaluate with respect to response. In this study it is one of the main objectives to include this kind of everyday patients that we see in the clinic.\n\nBecause of this we will be using TTF as the primary endpoint. Skeletal events requiring radiotherapy or major changes in pain medications are defined as treatment failures causing stop in treatment even in the absence of radiological findings.\n\nA: weekly Taxol® plus Xeloda® on days 1-14 q 3w B: Taxotere® q 3w plus Xeloda® on days 1-14 q 3w\n\nPatients are randomized equally between the two arms.\n\nConcomitant therapy: Simultaneous use of bisphosphonates is allowed, if this treatment has been initiated at least four weeks before study entry.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Morphologically proven breast carcinoma\n\nWritten informed patient consent Measurable and/or evaluable disease Measurable disease is defined as least one lesion that can be accurately measured in at least one dimension as ≥20 mm by conventional techniques, or as ≥10 mm by spiral CT scan) as defined in section 8.\n\nEvaluable metastases. Lytic bone metastases as only site of recurrence are allowed and can be evaluated for response according to the WHO-criteria for reporting on response in bone metastases.\n\nAge 18 years or older ECOG Performance Status 0-2 Life expectancy of at least three months Adequate cardiac functions\n\nAdequate hematological, renal and hepatic functions, defined as:\n\nWhite blood cell count \\> 3.9 x 109/L Trombocytes \\> 100 x 109/L Serum creatinine \\< 1.25 x ULN\\* Bilirubin \\< 1.5 ULN If alkaline phosphatases (ALP) is normal ALAT \\< 3.5 ULN ASAT \\< 3.5 ULN If alkaline phosphatases (ALP) is \\> 2.5 ULN ALAT \\< 1.5 ULN ASAT \\< 1.5 ULN\n\n\\-\n\nExclusion Criteria: Recurrence-free interval less than one year, if previous adjuvant or neoadjuvant regimen contained a taxane\n\nNeoplasm other than breast carcinoma, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix, diagnosed during the past five years\n\nPregnancy or lactation\n\nKnown brain metastases\n\nPreexisting motor or sensory neuropathy ≥ grade 2 according to NCI CTC 2.0 criteria (severe paresthesia and/or mild weakness, or worse)\n\nSevere hepatic or renal impairment (for capecitabine: calculated creatinine clearance below 30 ml/min; for calculation, see p. 5.1.4) not allowing for adequate use of the proposed regimens\n\nHistory of known dihydropyrimidine dehydrogenase (DPD) deficiency (severe reaction on previous treatment with fluorouracil)\n\nActive infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide, cyclosporine or vitamin K\n\nDementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00201435', 'briefTitle': 'Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian Breast Cancer Group'}, 'officialTitle': 'Weekly Taxol® Plus Xeloda® Versus Taxotere® Every Three Weeks Plus Xeloda® in the Treatment of Metastatic Breast Cancer A Phase II/III Study', 'orgStudyIdInfo': {'id': 'NBCG10'}, 'secondaryIdInfos': [{'id': 'REK 378-04-03133'}, {'id': 'NMA 03-07568'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Paclitaxel weekly in combination with capecitabine', 'type': 'DRUG'}, {'name': 'Docetaxel every 3 week in combination with capecitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevål university hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Erik Wist, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian Breast Cancer Group', 'class': 'OTHER'}}}}