Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 10:52 PM
Study NCT ID:
NCT01558492
Status:
TERMINATED
Last Update Posted:
2017-06-09
First Post:
2012-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hip9004@med.cornell.edu', 'phone': '646-962-2072', 'title': 'Himisha Beltran, MD', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Subjects', 'description': 'Carboplatin and Paclitaxel\n\nCarboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle\n\nPaclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Prostate-specific Antigen (PSA) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'Carboplatin and Paclitaxel\n\nCarboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle\n\nPaclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle'}], 'timeFrame': 'Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.'}, {'type': 'PRIMARY', 'title': 'Change in Tumor Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'Carboplatin and Paclitaxel\n\nCarboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle\n\nPaclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle'}], 'timeFrame': 'Baseline, week 12, week 24 and end of study.', 'description': 'Assessed by CT or MRI scan and/or bone scan.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Change in Survival Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'Carboplatin and Paclitaxel\n\nCarboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle\n\nPaclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle'}], 'timeFrame': '6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'Carboplatin and Paclitaxel\n\nCarboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle\n\nPaclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'Carboplatin and Paclitaxel\n\nCarboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle\n\nPaclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-05', 'studyFirstSubmitDate': '2012-02-16', 'resultsFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2012-03-16', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-28', 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Prostate-specific Antigen (PSA) Level', 'timeFrame': 'Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.'}, {'measure': 'Change in Tumor Size', 'timeFrame': 'Baseline, week 12, week 24 and end of study.', 'description': 'Assessed by CT or MRI scan and/or bone scan.'}], 'secondaryOutcomes': [{'measure': 'Change in Survival Status', 'timeFrame': '6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metastatic Castrate Resistant Prostate Cancer', 'CRPC'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel and correlate response to study treatment with biologic parameters (i.e. lab studies of blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into the underlying biology of prostate tumor progression and perhaps predict which patients may benefit from this chemotherapy regimen.', 'detailedDescription': 'Docetaxel/prednisone is the standard of care in patients with metastatic, castrate-resistant prostate cancer (CRPC) but duration of response is limited, with median time to prostate-specific antigen (PSA) progression of 6-8 months. There is currently no standard second-line therapy for patients who have progressed after receiving docetaxel. Carboplatin and paclitaxel have demonstrated activity, but prospective clinical trials evaluating this regimen are limited. In addition, correlative studies investigating why some patients respond are lacking.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic or cytologic diagnosis of prostate carcinoma.\n* Subject must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy. Furthermore, if applicable, medical castration must be maintained for the duration of the protocol.\n* Serum testosterone \\< 50 ng/ml.\n* Subjects who have received anti-androgen therapy with a resulting PSA decline must demonstrate progression following discontinuation of anti-androgen therapy.\n* Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial.\n* Must have previously received docetaxel for prostate cancer\n* ECOG performance status 0-2\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* Platelet count \\<100,000/mm3\n* Absolute neutrophil count (ANC) \\<1,500/mm3\n* Hemoglobin \\< 8 g/dL\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5 x upper limit of normal\n* Bilirubin (total) \\>2 x upper limit of normal. Subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits\n* For subjects with serum creatinine \\> 1.5 x ULN, calculated creatinine clearance \\< 30 ml/min are excluded; subjects meeting this exclusion criterion are eligible if a measured clearance is \\> 30 ml/min\n* Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study\n* Prior investigational therapy within 4 weeks of treatment. Furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase.\n* Grade \\> 1 peripheral neuropathy"}, 'identificationModule': {'nctId': 'NCT01558492', 'briefTitle': 'Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel', 'orgStudyIdInfo': {'id': '1008011188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'description': 'Carboplatin and Paclitaxel', 'interventionNames': ['Drug: Carboplatin', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'AUC = 5 intravenously (IV) on day 1 of a 28 day cycle', 'armGroupLabels': ['All subjects']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': '80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Himisha Beltran, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}