Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-28 @ 7:53 PM
Study NCT ID:
NCT00706069
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2008-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vinorelbine Oral Plus Capecitabine Combination In 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': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'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': '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-14', 'studyFirstSubmitDate': '2008-06-25', 'studyFirstSubmitQcDate': '2008-06-26', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination', 'timeFrame': 'Toxicity assessment at 1st cycle'}, {'measure': 'Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination.', 'timeFrame': 'Toxicity assessment at 1st cycle'}], 'secondaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': "Response evaluation at 3rd and 6th cycle by CT's or MRI"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metastatic Breast Cancer', 'Vinorelbine oral', 'Capecitabine'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients', 'detailedDescription': 'The combination capecitabine-vinorelbine, with iv administration of vinorelbine, has been studied in a phase \\[I\\]/\\[II\\], with favourable profile of toxicity in pretreated patients with anthracyclines and/or taxanes (Oncology News International vol 12, no 3, suppl 2, 2003).\n\nIn a study of toxicity and effectiveness, Vanhopher reported objective response rates (PR) in 21 from 45 patients (47%) and stabilization of disease (SD) in 16 patients (36%). Severe leucopenia (grade 4), was reported in 5% of patients (Borquez D, et al: Proc Am Soc Clin Oncol 19: Abstract 420, 2000)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed metastatic breast cancer\n* Age 18-75 years\n* Bidimensionally measurable or evaluable disease\n* Performance status (PS) 0-2 (ECOG)\n* Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment\n* Adequate liver (serum bilirubin \\<1.5 times the upper normal limit, AST and ALT \\<2.5 times the UNL 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 adequate bone marrow function(neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)\n* At least three weeks from completion of irradiation\n* Life expectancy ≥ 12 weeks\n* Patients able to take oral medication\n* written informed consent\n\nExclusion Criteria:\n\n* Active infection\n* Brain metastases\n* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)\n* Malnutrition (loss of ≥ 20% of the original body weight)\n* Psychiatric illness or social situation that would preclude study compliance\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00706069', 'briefTitle': 'Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Oncology Research Group'}, 'officialTitle': 'A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CT/07.06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Vinorelbine oral plus Capecitabine', 'interventionNames': ['Drug: Vinorelbine oral', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Vinorelbine oral', 'type': 'DRUG', 'otherNames': ['Navelbine oral'], 'description': 'Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday', 'armGroupLabels': ['1']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine at dose levels of 800 mg/m2, 950mg/m2, 1100mg/m2, 1250mg/m2 per os from day 1 to day 14 every 21 days', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University General Hospital of Alexandroupolis, Dept. of Medical Oncology', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"IASO" General Hospital of Athens, 1st Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Heraklion', 'country': 'Greece', 'facility': 'University Hospital of Crete, Dep of Medical Oncology', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}], 'overallOfficials': [{'name': 'Nikos Malamos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Oncology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Crete', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Nikos Malamos', 'oldOrganization': 'Hellenic Oncology Research Group'}}}}