Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT00225056
Status:
TERMINATED
Last Update Posted:
2007-04-20
First Post:
2005-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
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': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 43}}, 'statusModule': {'whyStopped': 'Terminated due to lack of accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-18', 'studyFirstSubmitDate': '2005-09-21', 'studyFirstSubmitQcDate': '2005-09-21', 'lastUpdatePostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall clinical benefit rate'}], 'secondaryOutcomes': [{'measure': 'safety and tolerability'}, {'measure': 'evaluate QOL'}, {'measure': 'determine progression free survival'}, {'measure': 'determine time to response and overall survival'}]}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ccihsv.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must have metastatic breast cancer\n* must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma\n* must have measurable or evaluable disease\n* ECOG of 0-1\n* patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer\n* must have adequate organ function\n* must be at least 19 years of age\n* peripheral neuropathy less than or equal to grade 1\n* must have voluntarily signed informed consent\n* patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled\n\nExclusion Criteria:\n\n* patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years\n* patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion\n* known uncontrolled existing coagulopathy\n* patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil\n* use of other investigational agents in the last 28 days\n* pregnant or lactating women\n* patients who are known HIV positive\n* patients with life expectancy of less than 3 months\n* sexually active patients unwilling to practice reliable contraception during the study'}, 'identificationModule': {'nctId': 'NCT00225056', 'briefTitle': 'Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Oncology Specialties, Alabama'}, 'officialTitle': 'Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma', 'orgStudyIdInfo': {'id': 'CCIBRE02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel and capecitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Comprehensive Cancer Institute', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}], 'overallOfficials': [{'name': 'John M Waples, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oncology Specialties, PC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oncology Specialties, Alabama', 'class': 'OTHER'}}}}