Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 1:59 AM
Study NCT ID:
NCT01535157
Status:
TERMINATED
Last Update Posted:
2020-08-27
First Post:
2012-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007654', 'term': 'Ketoconazole'}, {'id': 'D017313', 'term': 'Fenretinide'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'drug combination not providing any efficacy. Will use this data in opening new trial', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2012-02-03', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 2: Progression Free Survival', 'timeFrame': 'From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)', 'description': 'The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.'}, {'measure': 'Phase 2: Overall Survival', 'timeFrame': 'From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)', 'description': 'The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.'}, {'measure': 'Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole', 'timeFrame': 'From time of first dose to the last (average 6 months)', 'description': 'Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.'}, {'measure': 'Phase 2: Event Free Survival', 'timeFrame': 'From enrollment up to the first date of progressive disease or death from any cause (up to 48 months after last patient entered on treatment)', 'description': 'The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics -', 'timeFrame': 'up to 48 months after the last subject enrolled', 'description': 'Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chemotherapy'], 'conditions': ['Ovarian Cancer', 'Cancer of Ovary', 'Cancer of the Ovary', 'Ovary Neoplasms', 'Primary Peritoneal Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sponc.org', 'label': 'Click here for more information about the South Plains Oncology Consortium'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-HPR/LXS) is most effective alone.', 'detailedDescription': 'In this study, an initial Phase I component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-HPR) given together with ketoconazole'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent epithelial ovarian cancer or primary peritoneal carcinoma that can be platinum sensitive or platinum resistant\n* SWOG Performance Status 0-2\n* Previously received a platinum and paclitaxel containing regimen\n* Projected Life Expectancy of at least 3 months\n* Adequate bone marrow function\n* Adequate organ function\n* Must have received at least 1 prior salvage regimen for recurrent ovarian cancer\n* Recovery from acute toxicities from surgery, radiation or chemotherapy\n* At least 3 weeks from last therapy\n\nExclusion Criteria:\n\n* Prior fenretinide oral capsule use allowed. If prior IV fenretinide use, must contact study chair for eligibility\n* Second malignancy within last 5 years\n* Use of concomitant antioxidants, such as vitamin C or E\n* Untreated or symptomatic brain metastases\n* History of hypertriglyceride levels \\> 200 mg/dl; triglyceride levels \\< 200 and receiving treatment are okay.\n* Use of certain medications is prohibited - contact study coordinator for information'}, 'identificationModule': {'nctId': 'NCT01535157', 'briefTitle': 'Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer', 'nctIdAliases': ['NCT01550692'], 'organization': {'class': 'NETWORK', 'fullName': 'South Plains Oncology Consortium'}, 'officialTitle': 'Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma', 'orgStudyIdInfo': {'id': 'SPOC-2011-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fenretinide/LXS + Ketoconozale', 'description': 'One course is defined as 7 days of Fenretinide/LXS + Ketoconazole followed by 14 days of rest. A course is repeated every 21 days if no evidence of disease progression for six courses.', 'interventionNames': ['Drug: Fenretinide/LXS + Ketoconazole']}], 'interventions': [{'name': 'Fenretinide/LXS + Ketoconazole', 'type': 'DRUG', 'otherNames': ['4-HPR', 'N-(4-hydroxyphenyl)retinamide', 'Nizoral', 'Feoris'], 'description': 'Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day', 'armGroupLabels': ['Fenretinide/LXS + Ketoconozale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79416', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Joe Arrington Cancer Research and Treatment Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Jayanthi Lea, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Texas Southwestern Medical Center'}, {'name': 'Barry J Maurer, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Texas Tech University Health Sciences Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Plains Oncology Consortium', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}