Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00186420
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
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': 'D000077143', 'term': 'Docetaxel'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.', 'timeFrame': 'Following treatment'}], 'secondaryOutcomes': [{'measure': 'To evaluate the toxicity of taxotere and hormones given adjuvantly.', 'timeFrame': 'Following treatment'}, {'measure': 'To measure Quality of Life on this therapy.', 'timeFrame': 'Following treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Taxotere'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:\n\n * Node positive disease post-operatively\n * Capsule involvement\n * Seminal Vesicles involvement\n * Gleason score ≥ 8\n * \\>50% of core biopsies that are positive\n * Clinical Stage T2c and T3\n * Pre-op PSA \\> 15 plus Gleason score of 7\n\n * Age greater than 18\n * ECOG Performance Status 0-1\n * Serum creatinine \\<= 1.5 mg/dl\n * Granulocyte count \\>= 1500/m3, Hemoglobin \\> 8.0 g/dl, and platelet count \\>= 100,000/m3\n * Total bilirubin \\<= ULN\n * AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.\n * Signed patient informed consent.\n * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.\n\nExclusion Criteria:\n\n* Peripheral neuropathy \\> grade 1\n* History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.\n* Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.\n* Active infection within 14 days of beginning treatment\n* Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.\n* Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.'}, 'identificationModule': {'nctId': 'NCT00186420', 'briefTitle': 'Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation', 'orgStudyIdInfo': {'id': 'PROS0004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Taxotere', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Sandy Srinivas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aventis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Sandy Srinivas', 'investigatorAffiliation': 'Stanford University'}}}}