Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 4:31 AM
Study NCT ID:
NCT01196559
Status:
COMPLETED
Last Update Posted:
2015-02-18
First Post:
2010-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-14', 'studyFirstSubmitDate': '2010-09-03', 'studyFirstSubmitQcDate': '2010-09-07', 'lastUpdatePostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (complete response and partial response)', 'timeFrame': '16 weeks', 'description': "radiologically assessed response every two cycles, according to RECIST ver 1.1 criteria and serologically assessed CA 125 response every two cycles, according to Rustin's criteria"}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '6months', 'description': 'fom the date of enrollment until the date of confimed progressive disease or death'}, {'measure': 'overall survival', 'timeFrame': '1year', 'description': 'from the date of enrollment to death any cause'}, {'measure': 'Frequency and severity of adverse effects', 'timeFrame': 'every cycle , from enrollment until death', 'description': 'assesed by the NCI-CTCAE ver 3.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ovarian cancer'], 'conditions': ['Ovarian Cancer', 'Primary Peritoneal Cancer', 'Fallopian Tube Cancer']}, 'referencesModule': {'references': [{'pmid': '25462205', 'type': 'DERIVED', 'citation': 'Hong SH, Lee S, Kim HG, Lee HJ, Jung KH, Lee SC, Lee NR, Yun J, Woo IS, Park KH, Kim KH, Kim HY, Rha SY, Byun JH. Phase II study of gemcitabine and vinorelbine as second- or third-line therapy in patients with primary refractory or platinum-resistant recurrent ovarian and primary peritoneal cancer by the Korean Cancer Study Group (KCSG)_KCSG GY10-10. Gynecol Oncol. 2015 Feb;136(2):212-7. doi: 10.1016/j.ygyno.2014.11.017. Epub 2014 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the objective response rate and safety in platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients treated with vinorelbine and gemcitabine combination chemotherapy.', 'detailedDescription': 'Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must sign an approved informed consent form (ICF)\n* Histologically or cytologically confirmed epithelial ovarian/fallopian tube/primary peritoneal carcinoma\n* Patients had to have received a front-line, platinum/taxane based chemotherapy regimen\n* Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer or progressed within six months of completing the most recent platinum-based chemotherapy\n* Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 3 prior systemic cytotoxic regimens.\n* Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area and increased Ca 125\n* A \\>= 4 weeks interval between their last chemotherapy regimen and the start of study treatment\n* Age 20-75 years old\n* Performance status (WHO) 0-2\n* Life expectancy of at least three months\n* Adequate bone marrow function (absolute neutrophil count \\> 1000/mm\\^3, platelet count \\> 100000/mm\\^3, hemoglobin \\> 9 gr/mm\\^3)\n* Adequate liver (bilirubin \\< 1.5 times upper limit of normal and SGOT/SGPT \\< 2 times upper limit of normal) and renal function (creatinine \\< 2 mg/dl)\n\nExclusion Criteria:\n\n* prior therapy with vinorelbine or gemcitabine\n* treatment with \\> 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)\n* Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure, recent myocardial infarction or active infection.\n* Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).\n* Symptomatic central nervous system (CNS) metastasis.\n* Uncontrolled intestinal obstruction\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational\n* Pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT01196559', 'briefTitle': 'Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.', 'orgStudyIdInfo': {'id': 'KCSG GY10-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vinorelbine and Gemcitabine', 'description': 'Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks', 'interventionNames': ['Drug: Vinorelbine and Gemcitabine']}], 'interventions': [{'name': 'Vinorelbine and Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemcibine and Navelbine'], 'description': 'Gmcitabine 1000㎎/㎡ mix in normal saline 100ml iv for 30min andVinorelbine 25㎎/㎡ mix in normal saline 50 ml iv for 5-10min on D1 and 8 every 21 days cycle', 'armGroupLabels': ['Vinorelbine and Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinju', 'country': 'South Korea', 'facility': 'Gyeonsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '137-040', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae Ho Byun, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Incheon St.Mary;s hospital, Catholic University of Korea'}, {'name': 'Sook Hee Hong, AP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St.Mary's hospital, Catholic University of Korea"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korean Cancer Study Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Division of Medical Oncology, Multidisciplinary team of Gynecologic cancer, Seoul St. Mary's hospital", 'investigatorFullName': 'Sook Hee Hong', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}