Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 12:41 PM
Study NCT ID:
NCT00003633
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced 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': 'D004961', 'term': 'Estramustine'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D011241', 'term': 'Prednisone'}], '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': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1998-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-03', 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage IV prostate cancer', 'recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated doses of docetaxel and mitoxantrone in combination with a fixed dose of estramustine and prednisone, when given to patients with advanced prostate cancer.\n* Characterize the toxicity of this treatment regimen in these patients.\n\nOUTLINE: This is a dose escalation study of mitoxantrone and docetaxel. Patients are stratified into one of two risk groups (good risk group or poor risk group) based on the number of prior chemotherapy regimen(s) and the occurrence and sites(s) of prior radiation.\n\nAll patients receive oral prednisone twice daily on days 0-3, oral estramustine three times daily on days 1-5, mitoxantrone IV bolus on day 2, and docetaxel IV over 1 hour on day 2. Courses repeat every 21 days in the absence of unacceptable toxicity and disease progression. Patients with stable disease may go off treatment after 6 courses.\n\nDose escalation proceeds independently for each risk group. Cohorts of 3 patients are entered into each risk group. If 1 of 3 patients at a dose level experiences dose limiting toxicity (DLT), then 3 additional patients are accrued into this level. If 2 of 6 patients at a dose level experience DLT, then dose escalation stops and the maximum tolerated dose (MTD) is defined at the previous dose level. At least 6 patients must be treated at the MTD.\n\nPatients are followed every 3 months until death.\n\nPROJECTED ACCRUAL: At least 12 patients (6 in each risk group) will be accrued into this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria:\n\n * Rise in serum PSA greater than 50% of nadir confirmed on 2 measurements 1 week apart\n * Appearance of new lesions on bone scan\n * Appearance of new soft-tissue lesions\n* Measurable or evaluable disease\n* No brain or leptomeningeal involvement\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Greater than 3 months\n\nHematopoietic:\n\n* WBC at least 3,500/mm3\n* Absolute neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 5 times ULN\n* SGOT and SGPT no greater than 2 times ULN\n\nRenal:\n\n* Creatinine no greater than 2 times ULN\n\nCardiovascular:\n\n* No history of coagulopathy\n* No myocardial infarction in the last 6 months\n* No history of cardiovascular accident\n* No history of congestive heart failure\n\nNeurological:\n\n* No symptomatic peripheral neuropathy greater than grade 1\n* No history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures\n\nPulmonary:\n\n* No history of pulmonary embolus\n\nOther:\n\n* Testosterone no greater than 3.5 nmol/L\n* No contraindications to glucocorticoid therapy such as uncontrolled diabetes mellitus or active peptic ulcer disease\n* No active infection\n* No other serious illness or medical condition\n* No other concurrent or prior malignancy in the past 5 years except previously excised or curatively irradiated nonmelanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior hormonal therapy (including nonsteroidal antiandrogens, but not LHRH agonists)\n\nRadiotherapy:\n\n* No prior radiotherapy to greater than 30% of bone marrow\n* At least 6 weeks since isotope therapy\n* At least 4 weeks since prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* At least 4 weeks since prior investigational drugs'}, 'identificationModule': {'nctId': 'NCT00003633', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone', 'orgStudyIdInfo': {'id': 'CDR0000066717'}, 'secondaryIdInfos': [{'id': 'CPMC-IRB-8040'}, {'id': 'CPMC-IRB-8040-2/9173'}, {'id': 'NCI-V98-1487'}, {'id': 'CPMC-IRB-AAAA5741'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'estramustine phosphate sodium', 'type': 'DRUG'}, {'name': 'mitoxantrone hydrochloride', 'type': 'DRUG'}, {'name': 'prednisone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center at Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Daniel P. Petrylak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herbert Irving Comprehensive Cancer Center', 'class': 'OTHER'}}}}