Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-31 @ 1:57 AM
Study NCT ID:
NCT00093457
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib in Treating Patients With Metastatic or Recurrent 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': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2011-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2004-10-06', 'studyFirstSubmitQcDate': '2004-10-07', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostate-specific antigen response and/or progression', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Objective response and/or progression', 'timeFrame': '2 years'}, {'measure': 'Tolerability and toxicity', 'timeFrame': '2 years'}, {'measure': 'Time to treatment failure and overall patient survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent prostate cancer', 'stage IV prostate cancer', 'adenocarcinoma of the prostate'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '18056648', 'type': 'RESULT', 'citation': 'Chi KN, Ellard SL, Hotte SJ, Czaykowski P, Moore M, Ruether JD, Schell AJ, Taylor S, Hansen C, Gauthier I, Walsh W, Seymour L. A phase II study of sorafenib in patients with chemo-naive castration-resistant prostate cancer. Ann Oncol. 2008 Apr;19(4):746-51. doi: 10.1093/annonc/mdm554. Epub 2007 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.\n\nPURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate.\n\nSecondary\n\n* Determine the objective response rate and duration of response in patients treated with this drug.\n* Determine the tolerability and toxicity of this drug in these patients.\n* Determine time to treatment failure and overall survival in patients treated with this drug.\n* Explore the relationship between measures of ras/raf pathway activation (pERK) and response to treatment in these patients.\n\nOUTLINE: This is a non-randomized, multicenter study.\n\nPatients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 4 weeks after going off study treatment and then periodically for survival. Patients with stable or responding disease, when they go off study treatment, are followed every 3 months until relapse or progression.\n\nPROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n\n * Metastatic or recurrent disease\n* No curative standard therapy exists\n* Hormone-refractory disease\n\n * Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration\n\n * Documented PSA progression after completion of prior peripheral anti-androgens\n\n * At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart\n * Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation\n\n * Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation\n* PSA ≥ 10 ng/mL at the time of study entry\n* Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry\n* Minimal symptomatic disease\n\n * No requirement for morphine or equivalent dose \\> 30 mg/day to control pain\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute granulocyte count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* No evidence of bleeding diathesis\n\nHepatic\n\n* Bilirubin normal\n* AST and ALT ≤ 2.5 times upper limit of normal\n\nRenal\n\n* Serum creatinine normal OR\n* Creatinine clearance ≥ 60 mL/min\n\nCardiovascular\n\n* No myocardial infarction within the past 6 months\n* No congestive heart failure\n* No unstable angina\n* No active cardiomyopathy\n* No unstable ventricular arrhythmia\n* No uncontrolled hypertension\n\nOther\n\n* No serious infection\n* No active peptic ulcer disease\n* No upper gastrointestinal or other condition that would preclude study compliance with oral medication\n* No uncontrolled psychotic disorder\n* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents\n* No other serious illness or medical condition that would preclude study participation\n* No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or other curatively treated solid tumor\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other growth factors allowed for the management of adverse events only\n\nChemotherapy\n\n* No prior chemotherapy\n* No other prior cytotoxic chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* Concurrent steroids allowed provided there has been no increase in steroid requirements within the past 4 weeks AND no increase in dose is planned\n\nRadiotherapy\n\n* At least 4 weeks since prior external-beam radiotherapy except low-dose non-myelosuppressive radiotherapy\n* Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior investigational anticancer agents\n* No concurrent therapeutic anticoagulation\n\n * Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No other concurrent anticancer therapy\n* No other concurrent investigational therapy\n* No concurrent grapefruit juice\n* Concurrent bisphosphonates allowed'}, 'identificationModule': {'nctId': 'NCT00093457', 'briefTitle': 'Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'I167'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-IND167', 'type': 'OTHER', 'domain': 'PDQ'}, {'id': 'CDR0000387987', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'sorafenib tosylate', 'type': 'DRUG', 'description': 'BAY 43-9006 given orally at 400 mg BID in a 28 day cycle'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V1Y 5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Centre for the Southern Interior', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Margaret and Charles Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Program at London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Kim N. Chi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'British Columbia Cancer Agency'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}