Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-13 @ 3:32 AM
Study NCT ID:
NCT00115635
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
2005-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and Gemcitabine in Hormonal Refractory Metastatic 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': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-01', 'studyFirstSubmitDate': '2005-06-23', 'studyFirstSubmitQcDate': '2005-06-23', 'lastUpdatePostDateStruct': {'date': '2007-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostate-specific antigen (PSA) response'}], 'secondaryOutcomes': [{'measure': 'Clinical response'}, {'measure': 'Time to PSA progression'}, {'measure': 'Toxicity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hormonal refractory, chemotherapy, docetaxel, gemcitabine'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to efficacy and toxicity in a phase II trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically verified adenocarcinoma of the prostate.\n* Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.\n* Stage IV disease (verified by imaging or clinical examination).\n* PSA \\> 10 microgram/l.\n* PSA progression defined as a \\> 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.\n* Castrate level of testosterone (\\< 50 ng).\n* No previous oestrogen or steroid as metastatic prostate cancer treatment.\n* Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.\n* Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.\n* Satisfactory haematologic function defined as ANC \\>1.5 x 10\\^9/l, leucocytes \\>3.0 x 10\\^9/l, thrombocytes ≥ 100 x 10\\^9/l, haemoglobin \\> 7 mmol/l\n* ECOG performance status ≤ 2.\n* Life expectancy \\> 3 months.\n* Patient must be able to adhere to protocol requirements.\n* Written informed consent.\n* \\> 18 years of age.\n\nExclusion Criteria:\n\n* Previous prostate cancer treatment with oestrogens or steroid hormones.\n* Previous chemotherapy.\n* Previous treatment with systemic radioactive isotopes.\n* Bisphosphonate treatment (concomitant).\n* Radiation therapy covering more than 25% of the bone marrow producing area.\n* Other serious coincidental and/or concomitant medical condition.\n* Symptomatic cerebral metastases.\n* Other previous or current malignant disease, excluding \\*adequately treated and cured planocellular skin carcinoma; or \\*other cancer assessed to carry minimal risk of recurrence.\n* ECOG performance status \\> 2.'}, 'identificationModule': {'nctId': 'NCT00115635', 'briefTitle': 'Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer', 'orgStudyIdInfo': {'id': 'UR0416'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2004-002353-31'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'gemcitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Dept. of Oncology, 54B1, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Lisa Sengelov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}]}}}