Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-06 @ 11:08 AM
Study NCT ID:
NCT01487720
Status:
COMPLETED
Last Update Posted:
2013-12-03
First Post:
2011-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GEMOX in Docetaxel-Refractory Castration-Resistant 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-30', 'studyFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA response', 'timeFrame': '6 months', 'description': 'Based on PCWG 1.0'}], 'secondaryOutcomes': [{'measure': 'PSA decline', 'timeFrame': '6 months', 'description': 'Based on PCWG 2.0'}, {'measure': 'Time to PSA progression', 'timeFrame': '12 months'}, {'measure': 'Composite progression-free survival', 'timeFrame': '12 months', 'description': 'Based on RECIST, bone scan, and performance status'}, {'measure': 'RECIST Response', 'timeFrame': '6 months', 'description': 'Based on RECIST v 1.1'}, {'measure': 'Safety', 'timeFrame': '6 months', 'description': 'Based on NCI CTCAE v. 4.03'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Castration-resistant prostate cancer', 'Docetaxel-refractory status'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Prostate cancer is one of the most common malignancies affecting men all over the World. Metastatic prostate cancer responds to androgen deprivation for a variable period (20-25 months). Prostate cancer that grows despite castrate levels of testosterone and that no longer responds to any form of hormonal manipulation is defined as castrate resistant prostate cancer (CRPC).\n\nDocetaxel combined with prednisolone has been shown to not only improve QOL and PSA response in CRPC, but also extend the overall survival1. However, the efficacy of the drug has not been universally effective, and nearly all patients have disease progression after docetaxel treatment.\n\nAfter failure of a docetaxel regimen, With the exception of cabazitaxel or abiraterone, which are not widely and easily availabe in Korea, little treatment regimen can be applied to the patients with reasonable response and benefits.\n\nGemcitabine is a nucleoside analog with activity against a broad spectrum of solid tumors. When gemcitabine is used as first-line therapy for CRPC, disease control rate was 33% with median duration of 7.1 months. When it is combined with prednisone and zoledronic acid in pretreated patients with CRPC, the PSA response rate was 23% with a disease control rate of 57% in patients with measurable disease.\n\nOxaliplatin is newer platinum agent that has favorable toxicity profile and evidence of activity in cisplatin-resistant cell lines. Droz et al. performed a multicenter phase II study in 54 patients with metastatic CRPC who were randomized to receive oxaliplatin either alone or with 5-FU. More than 50% of the patients had received prior chemotherapy including cisplatin. Despite heavy pretreatment, PSA desclines were noted in 11% and 19% of patients in each arm.\n\nGemcitabine plus oxaliplatin combination was widely studied and has been reported to be safe and effective in various cancers.\n\nThis study is to assess the efficacy and safety of GEMOX in docetaxel-refractory CRPC.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Clinical or radiologic evidence of metastatic disease\n* Documented disease progression during hormone therapy (ADT plus antiandrogen) and no response to ADT withdrawal\n* Docetaxel-refractory disease defined as disease progression documented either during treatment of within 60 days after the cessation of treatment with docetaxel\n* Prior exposure to estramustine or mitoxantrone is allowed\n* KPS ≥ 60\n* No prior radioisotope therapy\n* No prior radiotherapy 25% or more of the bone marrow\n* No peripheral neuropathy grade 2 or worse\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Other tumor type than adenocarcinoma\n* Presence or history of CNS metastasis\n* Other serious illness or medical conditions'}, 'identificationModule': {'nctId': 'NCT01487720', 'briefTitle': 'GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Prosepctive Phase II Study of Gemcitabine and Oxaliplatin in Combination With Prednisolone for the Treatment of Hormone Refracotry Metastatic Prostate Cancer Previously Treated With Docetaxel Regimen', 'orgStudyIdInfo': {'id': 'UOSG-AMC-0802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GEMOX', 'description': 'GEMOX treatment', 'interventionNames': ['Drug: GEMOX']}], 'interventions': [{'name': 'GEMOX', 'type': 'DRUG', 'description': 'Gemcitabine 1000 mg/m2 IV on day 1 every 2 weeks (fixed-dose rate 10 mg/m2/min) Oxaliplatin 100 mg/m2 IV on day 1 every 2 weeks Prednisolone 5 mg twice a day orally daily', 'armGroupLabels': ['GEMOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'JLee', 'investigatorAffiliation': 'Asan Medical Center'}}}}