Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT02437812
Status:
UNKNOWN
Last Update Posted:
2017-02-28
First Post:
2015-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '5 years', 'description': 'The primary outcome of progression free survival will compare the percentage of those who have either progressed or died at 1 year with those who were at risk for at least 1 year.'}], 'secondaryOutcomes': [{'measure': 'Metabolic biomarker evaluation', 'timeFrame': '3 months', 'description': 'Glucose (mg/dL)'}, {'measure': 'Metabolic biomarker evaluation', 'timeFrame': '3 months', 'description': 'Fasting insulin (mIU/L)'}, {'measure': 'Metabolic biomarker evaluation', 'timeFrame': '3 months', 'description': 'BMI (kg/m2)'}, {'measure': 'Metabolic biomarker evaluation', 'timeFrame': '3 months', 'description': 'Urine (mOsm/kg)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epithelial Ovarian Carcinoma']}, 'descriptionModule': {'briefSummary': "Initially, the prospect of metformin as a neoplastic treatment was considered for malignancies of the prostate, colon and pancreas. However, only select clinical studies involving the use of metformin in the treatment of ovarian cancer have documented improved survival rates. Since no first line regimen has demonstrated compelling superiority in the management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin, and metformin is of particular interest given the triplet's prospect for achieving increased synergy without compromising patient tolerability.", 'detailedDescription': 'A phase II, open-label, non-randomized, pilot study assessing the safety, toxicity, and progression free survival of advanced stage ovarian carcinoma patients who underwent treatment with paclitaxel, carboplatin and metformin. An estimated 30 patients will be required for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale Gender\n\nAge greater than 18 years\n\nAdvanced stage epithelial ovarian, fallopian tube, or primary peritoneal cancer\n\nAdequate bone marrow function\n\nECOG performance score of 2 or greater\n\nPatients must be able to swallow oral medication.\n\nExclusion Criteria:\n\nSubjects must NOT be taking metformin or have been on metformin in the past 6 months.\n\nSubjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas)\n\nSubjects with concomitant malignancy or a previous malignancy within the past three years, melanoma skin cancer excepted'}, 'identificationModule': {'nctId': 'NCT02437812', 'briefTitle': 'Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Gynecologic Oncology Associates'}, 'officialTitle': 'A Phase II, Open-Label, Non-Randomized, Pilot Study of Paclitaxel, Carboplatin and Oral Metformin for Patients Newly Diagnosed With Stage II-IV Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma', 'orgStudyIdInfo': {'id': 'GOA-TCOM1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel, carboplatin and metformin', 'description': 'Drug: Metformin (850 mg) Drug: Carboplatin (AUC 5 or 6) Drug: Paclitaxel (80 mg/m2)\n\nThe regimen will be administered as a dose dense schedule.', 'interventionNames': ['Drug: Metformin', 'Drug: Paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Metformin with standard chemotherapy', 'armGroupLabels': ['Paclitaxel, carboplatin and metformin']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'Standard chemotherapy', 'armGroupLabels': ['Paclitaxel, carboplatin and metformin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Carbo'], 'description': 'Standard chemotherapy', 'armGroupLabels': ['Paclitaxel, carboplatin and metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katrina Lopez, CCRC', 'role': 'CONTACT', 'email': 'Katrinal@gynoncology.com', 'phone': '949-642-5165', 'phoneExt': '259'}], 'facility': 'Gynecologic Oncology Associates', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'centralContacts': [{'name': 'Lisa N Abaid, M.D., M.P.H.', 'role': 'CONTACT', 'email': 'Research@gynoncology.com', 'phone': '949-642-1361'}, {'name': 'Katrina Lopez, CCRC', 'role': 'CONTACT', 'email': 'Katrinal@gynoncology.com', 'phone': '949-642-5165', 'phoneExt': '259'}], 'overallOfficials': [{'name': 'Lisa N Abaid, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecologic Oncology Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared once all data is reviewed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Associates', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}