Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT00754351
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2008-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docetaxel, Gemcitabine and Bevacizumab for 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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2008-09-17', 'studyFirstSubmitQcDate': '2008-09-17', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '1 year'}, {'measure': 'Toxicity profile', 'timeFrame': '21 days'}, {'measure': 'Overall Survival', 'timeFrame': '1 year'}, {'measure': 'Quality of life assessment', 'timeFrame': 'Assessment every two cycles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['docetaxel', 'gemcitabine', 'bevacizumab', 'chemotherapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer.', 'detailedDescription': 'Docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. Administered every two weeks, this combination has a favorable toxicity profile, and promising activity in \\> 1st line treatment for metastatic breast cancer. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically- or cytologically- confirmed metastatic breast adenocarcinoma\n* No HER2 overexpression or gene amplification\n* At least one previous chemotherapy regimen for metastatic breast cancer\n* Age ≥18 years\n* Performance status (WHO) 0-2\n* Life expectancy of at least 12 weeks\n* Measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm\n* Performance status (WHO) 0-2\n* Adequate liver function (serum bilirubin \\<1.5 times the upper normal limit, AST and ALT \\<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \\<5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine \\<1.5 times the upper normal limit) and bone marrow ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL) function\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Progressive brain metastases according to clinical or radiological criteria\n* Brain metastases without prior radiation therapy\n* Radiation therapy within the previous 4 weeks\n* Previous radiation therapy to the only measurable lesion\n* Proteinuria ≥ 500 mgr of protein daily\n* Uncontrolled hypertension\n* Documented hemorrhagic diathesis or coagulation disorder\n* Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF \\< normal, ventricular arrhythmia, uncontrolled hypertension)\n* Thrombotic event within the previous 6 months\n* Concurrent use of aspirin \\> 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents\n* Major surgical procedure within the previous 4 weeks\n* Presence of nonhealing wound or fracture\n* Peripheral neuropathy \\> grade 2 according to the NCI CTCAE (version 3.0)\n* Any sustained chronic toxicity \\> grade 2 according to the NCI CTCAE (version 3.0)\n* Uncontrolled infection\n* Any serious, uncontrolled comorbidity on the investigator's judgment\n* Other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer\n* Serious psychiatric illness"}, 'identificationModule': {'nctId': 'NCT00754351', 'briefTitle': 'Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Crete'}, 'officialTitle': 'Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CT/08.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bevacizumab-\\>Docetaxel-\\>Gemcitabine', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Docetaxel', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression', 'armGroupLabels': ['1']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles', 'armGroupLabels': ['1']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'University Hospital of Crete, Dep of Medical Oncology', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University General Hospital of Alexandroupolis, Dep of Medical Oncology', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'overallOfficials': [{'name': 'Dimitris Mavrudis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Crete, Dep of Medical Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Crete', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. D. Mavroudis', 'investigatorFullName': 'Vassilis Georgoulias, MD', 'investigatorAffiliation': 'University Hospital of Crete'}}}}