Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-11 @ 3:06 AM
Study NCT ID:
NCT02911350
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat 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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) assessment', 'timeFrame': '8 weeks', 'description': 'The MTD will be the lowest dose at which 2/6 or 2/3 patients experience dose limiting toxicity (DLT)'}, {'measure': 'Number of participants with qualitative and quantitative toxicities', 'timeFrame': 'up to 8 months'}]}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study:\n* Biopsy proven prostate cancer with Gleason score \\> 7\n* Pathologic staging TXN1 (on MRI or CT)\n* Prostate-specific antigen (PSA) \\> 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and \\> 10 days after prostate biopsy.\n\nIn addition patients must also have:\n\n* Performance status \\< 2\n* Hemoglobin \\> 11 grams per deciliter (g/dL), White blood cell (WBC) \\> 4000 and platelet count \\> 100.000/l\n* No evidence of other synchronous primary. Prior malignancies does not exclude if the patient is disease free \\> 5 years.\n* Prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and\n* Received hormone therapy with any of the following combination for less than 3 months\n* Lupron / Flutamide\n* Zoladex/ Flutamide\n* Lupron/ Casodex\n* Zoladex/ Casodex\n\nExclusion Criteria:\n\n* Clinical stage T1N0, PSA \\< 10, and Gleason score less than 7.\n* Evidence of distant metastasis\n* Previous surgery for prostate cancer (radical prostatectomy).\n* Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer\n* Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up.\n* Bilirubin \\> 1.5\n* Prior chemotherapy is not allowed"}, 'identificationModule': {'nctId': 'NCT02911350', 'briefTitle': 'Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer', 'orgStudyIdInfo': {'id': '9076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hormone Suppressors, Paclitaxel & Radiation therapy', 'description': 'Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months:\n\n1. Lupron / Flutamide\n2. Zoladex/ Flutamide\n3. Lupron/ Casodex\n4. Zoladex/ Casodex\n\nPaclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday \\& Wednesday or Tuesday \\& Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) \\& 45 mg/m2 (dose level VI).\n\nRadiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study.', 'interventionNames': ['Drug: Hormone Suppressors', 'Drug: Paclitaxel', 'Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Hormone Suppressors', 'type': 'DRUG', 'armGroupLabels': ['Hormone Suppressors, Paclitaxel & Radiation therapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane'], 'armGroupLabels': ['Hormone Suppressors, Paclitaxel & Radiation therapy']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'armGroupLabels': ['Hormone Suppressors, Paclitaxel & Radiation therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicholas Sanfilippo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Perlmutter Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}