Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 1:06 AM
Study NCT ID:
NCT00049257
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2002-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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': 'FKabbina@mednet.ucla.edu', 'phone': '310 824 1934', 'title': 'Dr. Fairooz Kabbinavar, Chief Medical Officer', 'organization': 'Translational Oncology Research International'}, 'certainAgreement': {'otherDetails': "The obligations of confidentiality shall apply for a period of 5 yrs beyond termination of Agreement between Sponsor and Investigator,but do not apply to the extent information:is or later becomes known to public;is obtained from a third party without restriction who had a legal right to disclose;is possessed by Investigators,as demonstrated by recipient's written records predating receipt from Sponsor;is required to be disclosed pursuant to a subpoena, law, regulation or other legal proceeding.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The major weakness of the study is, it is a single-arm non-comparative study. With the small sample size of 58 participants who received treatment, the study does not have the statistical power to make categorical assessments or statements.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately', 'description': 'Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Carboplatin, Paclitaxel', 'description': 'Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.', 'otherNumAffected': 58, 'seriousNumAtRisk': 58, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 45}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Neuropathy-sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Edema, limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, extremity-lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Pain, Not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'mood alteration-depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'taste alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hemorrhage pulmonary- nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, head', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'neuropathy-motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'infection-upper airway not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'cold symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'infection- urinary tract not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'mood alteration- anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'ALT, elevated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, chest- non-cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'alkaline phosphatase, elevated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'AST, elevated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain-urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'flu-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hyperphosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hypomagnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'mucositis-oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'nail changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'pain, neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'voice changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}], 'seriousEvents': [{'term': 'Deep Verin Thrombosis with Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Subarachnoid Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Urinary retention with acute hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Death secondary to cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Anaphylaxix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Hyperglycemia and diabetic management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Gall stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'spinal injury; inability to walk or stand ultimately caused death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v2.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prostate-specific Antigen (PSA) Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboplatin, Paclitaxel', 'description': 'Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.'}], 'classes': [{'title': 'Participants with PSA response', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Participants with no PSA response', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.', 'description': 'PSA response is defined as a decline from the baseline value of \\>=50% confirmed by a second PSA value 4 or more weeks later.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to PSA Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboplatin, Paclitaxel', 'description': 'Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '394'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Evaluated every 28 days during Treatment Period', 'description': 'In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by \\>=5ng/ml, confirmed by a second value at \\>=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is \\>=5ng/ml and is confirmed by a second value at \\>=4 week intervals.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboplatin, Paclitaxel', 'description': 'Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.'}], 'classes': [{'title': 'Participants with Complete Response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Partial Response', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Stable Disease', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Progression of Disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluated every 12 weeks during Treatment Period', 'description': 'Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of \\<50% and lesions with an estimated increase of \\<25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be \\>=25% or appearance of new lesions. Need for radiotherapy is considered PD.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboplatin, Paclitaxel', 'description': 'Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.'}], 'classes': [{'title': 'Deceased', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Alive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lost to Follow-up', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal by subject', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed every two months after completion of study treatment for 4 years', 'description': 'Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of \\<50% and lesions with an estimated increase of \\<25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be \\>=25% or appearance of new lesions. Need for radiotherapy is considered PD.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carboplatin, Paclitaxel', 'description': 'Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.'}], 'periods': [{'title': 'Carboplatin, Paclitaxel', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '13 participants did not complete treatment', 'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Follow-up Period for Survival Status', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Date of recruitment period: 10/02/2002- 5/25/2006. Types of location: Academic Medical clinics and community medical clinics. This study has 1 treatment arm; therefore randomization procedures were not utilized and all participants were enrolled to the same treatment regimen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Carboplatin, Paclitaxel', 'description': 'Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2002-11-12', 'resultsFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-02-10', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostate-specific Antigen (PSA) Response Rate', 'timeFrame': 'Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.', 'description': 'PSA response is defined as a decline from the baseline value of \\>=50% confirmed by a second PSA value 4 or more weeks later.'}, {'measure': 'Time to PSA Progression', 'timeFrame': 'Evaluated every 28 days during Treatment Period', 'description': 'In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by \\>=5ng/ml, confirmed by a second value at \\>=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is \\>=5ng/ml and is confirmed by a second value at \\>=4 week intervals.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Evaluated every 12 weeks during Treatment Period', 'description': 'Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of \\<50% and lesions with an estimated increase of \\<25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be \\>=25% or appearance of new lesions. Need for radiotherapy is considered PD.'}, {'measure': 'Overall Survival Rate', 'timeFrame': 'Assessed every two months after completion of study treatment for 4 years', 'description': 'Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of \\<50% and lesions with an estimated increase of \\<25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be \\>=25% or appearance of new lesions. Need for radiotherapy is considered PD.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'recurrent prostate cancer', 'stage IV 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: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the prostate-specific antigen (PSA) response rate and time to PSA progression in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel and carboplatin.\n* Determine the objective response rate, time to measurable or evaluable disease progression, and overall survival in patients treated with this regimen.\n* Determine the safety and toxicity of this regimen in these patients.\n\nOUTLINE: This is an open-label study.\n\nPatients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.\n\nPROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be informed of investigational nature of the study and written informed consent must be obtained prior to study entry\n* Patients \\>18 years of age\n* Patients with a histologic diagnosis of adenocarcinoma of the prostate\n* Patients must have metastatic disease with progression despite androgen ablation. Patients who have not undergone orchiectomy must continue LHRH analogues. For patients receiving LHRH analogues their testosterone level must be \\< 50ng/dL\n* Patients with bidimensionally measurable disease or bone metastases that is not progressive but who have a rising PSA are eligible\n* Patients with an ECOG performance status \\<2\n* Patients must have discontinued flutamide or nilutamide at least 4 weeks prior to the first day of treatment with evidence of progressive disease. Patients must have discontinued bicalutamide at least 6 weeks prior to registration with evidence of progressive disease\n* Patients with adequate hematological, renal, and hepatic function as defined by the following required laboratory values:\n\n * While blood cell count: \\> 3,000/mm3\n * Absolute granulocyte count: \\> 1,500/mm3\n * Platelets: \\> 100,000/mm3\n * Hemoglobin: \\> 8.5 g/dL\n * Total bilirubin: \\< 1.5 mg/dL\n * Serum creatinine: \\< 2.5 mg/dL\n * AST or ALT: \\< 2.5 x institutional upper limit of normal\n* Patients may have received prior radiation therapy, provided at least 4 weeks have elapsed since the conclusion of radiation therapy\n\nExclusion Criteria:\n\n* Patients with biochemical only progression\n* Patients who have received any prior chemotherapy for cancer of the prostate\n* Patients who received antiandrogen therapy within 4 weeks prior to the first day of treatment after cessation of flutamide or nilutamide, and or within 6 weeks prior to registration after cessation of bicalutamide\n* Patients receiving concomitant chemotherapy, biologic therapy, or radiation therapy\n* Patients who have received Strontium 89 or other radioisotope therapies\n* Patients with decreasing PSA levels following antiandrogen withdrawal\n* Patients with \\> grade 1 peripheral sensory or motor neuropathy\n* Patients with known carcinomatous meningitis or brain metastases are excluded\n* Patients with past or current histories of neoplasm other than entry diagnosis except for in-situ carcinoma of any site, non-melanoma skin cancer, or other malignancy treated by surgery or radiation with a disease-free survival longer than 5 years\n* Patients who have undergone major surgery \\< 3 weeks prior to registration, except for biopsy or placement of a venous access device. Patients must have fully recovered from all effects of any prior surgery\n* Patients with histories of serious cardiac disease not adequately controlled: documented myocardial infarction within the last 6 months preceding registration, congestive heart failure, unstable angina, valvular disease with documented ventricular compromise, uncontrolled hypertension, arrhythmia uncontrolled by medication, clinically significant pericardial effusion\n* Patients with active serious infections or other serious underlying medical conditions that would otherwise impair their ability to receive protocol treatments\n* Patients with dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent\n* Patients receiving other investigational therapy\n* Use of any investigational agent within 30 days of first day of treatment and use of Ketoconazole, hydrocortisone, glucocorticoids, or megace within 30 days of first day of treatment or other concomitant medications'}, 'identificationModule': {'nctId': 'NCT00049257', 'briefTitle': 'Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)', 'orgStudyIdInfo': {'id': 'CDR0000258050'}, 'secondaryIdInfos': [{'id': 'UCLA-0202092'}, {'id': 'BMS-UCLA-020209201'}, {'id': 'NCI-G02-2121'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Please see intervention descriptions', 'interventionNames': ['Drug: carboplatin', 'Drug: paclitaxel']}], 'interventions': [{'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'Administered Day 1 of each cycle. AUC=6.', 'armGroupLabels': ['Treatment']}, {'name': 'paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'administered Days 1, 8, and 15 of each cycle. 100mg/m2', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Fairooz F. Kabbinavar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}