Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00193102
Status:
TERMINATED
Last Update Posted:
2011-05-03
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thalidomide in Combination With Capecitabine in Patients 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': 'D013792', 'term': 'Thalidomide'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'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': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-02', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '18 Months'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20210519', 'type': 'RESULT', 'citation': 'Burris HA 3rd, Jones SF, Shipley D, Meluch AA, Greco FA, Barton JH, Yardley DA, Hainsworth JD. Phase II study of capecitabine in combination with thalidomide in patients with metastatic breast cancer. Cancer Invest. 2010 May;28(4):408-12. doi: 10.3109/07357901003631049.'}]}, 'descriptionModule': {'briefSummary': 'The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.', 'detailedDescription': 'Upon determination of eligibility, patients will be receive:\n\nThalidomide + Capecitebine'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be included in this study, you must meet the following criteria:\n\n* Metastatic breast cancer confirmed by biopsy\n* Measurable or evaluable disease\n* Females \\> 18 years\n* Able to perform activities of daily living with minimal assistance\n* Life expectancy \\> 3 months\n* Adequate bone marrow, liver and kidney function\n* All patients must give written informed consent in order to participate.\n\nExclusion Criteria:\n\nYou cannot participate in this study if any of the following apply to you:\n\n* Women who are pregnant or lactating.\n* Received more than 3 prior chemotherapy regimens in the metastatic setting.\n* Received continuous infusion 5-fluorouracil lasting \\> 120 hours.\n* Received thalidomide or capecitabine as their last prior regimen.\n* Preexisting moderate to severe neuropathy\n\nPlease note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.'}, 'identificationModule': {'nctId': 'NCT00193102', 'briefTitle': 'Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'SCRI Development Innovations, LLC'}, 'officialTitle': 'Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'SCRI BRE 60'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thalidomide', 'type': 'DRUG', 'description': 'Thalidomide'}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Howard Burris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SCRI Development Innovations, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCRI Development Innovations, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'SCRI Oncology Research Consortium', 'oldOrganization': 'SCRI'}}}}