Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00077402
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2004-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017313', 'term': 'Fenretinide'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2004-02-10', 'studyFirstSubmitQcDate': '2004-02-11', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate as measured by RECIST at ≥ 9 weeks'}], 'secondaryOutcomes': [{'measure': 'Toxicity as measured by NCI CTC'}]}, 'conditionsModule': {'keywords': ['recurrent prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer', 'adenocarcinoma of the prostate'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '20082080', 'type': 'RESULT', 'citation': 'Moore MM, Stockler M, Lim R, Mok TS, Millward M, Boyer MJ. A phase II study of fenretinide in patients with hormone refractory prostate cancer: a trial of the Cancer Therapeutics Research Group. Cancer Chemother Pharmacol. 2010 Oct;66(5):845-50. doi: 10.1007/s00280-009-1228-x. Epub 2010 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: This phase II trial is studying how well fenretinide works in treating patients with advanced or metastatic hormone-refractory prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA) response rate, in patients with advanced or metastatic hormone-refractory prostate cancer.\n\nSecondary\n\n* Determine the objective response rate in patients with identifiable soft tissue disease treated with this drug.\n* Determine the duration of PSA response in patients treated with this drug.\n* Determine PSA progression-free survival of patients treated with this drug.\n* Determine overall survival of patients treated with this drug.\n* Determine the toxicity of this drug in these patients.\n* Determine self-rated symptoms, functions, attitudes to oral therapy, and quality of life of patients treated with this drug.\n\nOUTLINE: This is a multicenter, open-label study.\n\nPatients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, before each course, and at the end of therapy.\n\nPROJECTED ACCRUAL: Approximately 21-50 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n\n * Measurable or non-measurable disease\n * Metastatic disease allowed\n* Castrate levels of serum testosterone (either after orchiectomy or maintained on a luteinizing hormone-releasing hormone agonist or antagonist)\n* Prostate-specific antigen (PSA) greater than 10 ng/mL at baseline and rising, with 2 consecutive increases measured at least 1 week apart\\*\n* No known brain metastases NOTE: \\*If the third PSA value has not risen above the second PSA value, a fourth measurement must be obtained that is higher than the second value\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* More than 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count greater than 1,500/mm\\^3\n* WBC greater than 3,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n\nHepatic\n\n* AST and ALT no greater than 2.5 times upper limit of normal\n* Bilirubin normal\n\nRenal\n\n* Creatinine normal OR\n* Creatinine clearance greater than 60 mL/min\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nOther\n\n* Able to tolerate oral medication\n* Fertile patients must use effective contraception\n* No prior allergic reaction to compounds of similar chemical or biological composition to fenretinide\n* No other concurrent uncontrolled illness\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior cytotoxic chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* At least 6 weeks since prior antiandrogen therapy with any of the following:\n\n * Cyproterone\n * Flutamide\n * Bicalutamide\n * Nilutamide\n* Concurrent corticosteroids allowed provided therapy was initiated before study entry\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy and recovered\n* No concurrent radiotherapy, including for pain\n* No concurrent radioisotopes (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)\n\nOther\n\n* More than 4 weeks since prior investigational agents\n* No concurrent antioxidants (e.g., ascorbic acid or vitamin E), vitamin A, or beta carotene supplements\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No other concurrent investigational or commercial anticancer agents or therapies'}, 'identificationModule': {'nctId': 'NCT00077402', 'briefTitle': 'Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'CTRG-P18/02'}, 'secondaryIdInfos': [{'id': 'CDR0000350305', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-6062'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fenretinide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Cancer Centre at Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital - Perth', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Shatin, New Territories', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital'}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Cancer Institute at National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Centre - Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Johns Hopkins Singapore International Medical Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Michael Boyer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sydney Cancer Centre at Royal Prince Alfred Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Therapeutics Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}