Nctid:
NCT00001266
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000011469", "term"=>"Prostatic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostatic Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000013498", "term"=>"Suramin"}], "ancestors"=>[{"id"=>"D000000969", "term"=>"Antinematodal Agents"}, {"id"=>"D000000871", "term"=>"Anthelmintics"}, {"id"=>"D000000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000014344", "term"=>"Trypanocidal Agents"}, {"id"=>"D000000981", "term"=>"Antiprotozoal Agents"}], "browseLeaves"=>[{"id"=>"M19090", "name"=>"Leuprolide", "relevance"=>"LOW"}, {"id"=>"M8612", "name"=>"Flutamide", "relevance"=>"LOW"}, {"id"=>"M4059", "name"=>"Androgens", "relevance"=>"LOW"}, {"id"=>"M16279", "name"=>"Suramin", "asFound"=>"AMD3100", "relevance"=>"HIGH"}, {"id"=>"M218326", "name"=>"Hydroxyflutamide", "relevance"=>"LOW"}, {"id"=>"M4196", "name"=>"Anthelmintics", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>70}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1990-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2003-08", "completionDateStruct"=>{"date"=>"2003-08"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Bayesian", "Hydroxy-Flutamide", "Combined Androgen Ablation", "Prostate Specific Antigen"], "conditions"=>["Prostatic Neoplasm"]}, "referencesModule"=>{"references"=>[{"pmid"=>"2465303", "type"=>"BACKGROUND", "citation"=>"Ashby H, DiMattina M, Linehan WM, Robertson CN, Queenan JT, Albertson BD. The inhibition of human adrenal steroidogenic enzyme activities by suramin. J Clin Endocrinol Metab. 1989 Feb;68(2):505-8. doi: 10.1210/jcem-68-2-505."}, {"pmid"=>"3279409", "type"=>"BACKGROUND", "citation"=>"Belanger A, Giasson M, Couture J, Dupont A, Cusan L, Labrie F. Plasma levels of hydroxy-flutamide in patients with prostatic cancer receiving the combined hormonal therapy: an LHRH agonist and flutamide. Prostate. 1988;12(1):79-84. doi: 10.1002/pros.2990120110."}, {"pmid"=>"1690883", "type"=>"BACKGROUND", "citation"=>"Badalament RA, Drago JR. Prostate cancer. Promising advances that may alter survival rates. Postgrad Med. 1990 Apr;87(5):65-7, 70-2. doi: 10.1080/00325481.1990.11704627."}]}, "descriptionModule"=>{"briefSummary"=>"One current hypothesis as to what limits duration of initial hormone response is the rapid emergence of hormone resistant prostate carcinoma cells. Suramin has shown effectiveness as a treatment for hormonally refractory prostate carcinoma. Survival was less in patients with high rather than low circulating androgen levels. Thus, suramin might slow the emergence of hormone refractory tumor cells while combined androgen ablation may maximize the effectiveness of suramin. In this trial, we will pilot this concept.", "detailedDescription"=>"The purpose of this study is to assess the potential for combined androgen blockage (Leuprolide and Flutamide), given with suramin (a growth factor inhibitor) to improve the clinical outcome(s) in a cohort of patients with bulky metastatic prostate cancer. Combined androgen blockage is currently the standard of care for such individuals. Suramin has shown reproducible activity in individuals with androgen independent disease. Since these two approaches are independent of one another - on the molecular level, and in clinical results - it is hoped that the combination of these two approaches will result in improved response rates and in improved survival."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"INCLUSION CRITERIA:\n\nPatients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.\n\nPatients must be 18 years of age and an SGOT/SGPT within 2 times of normal.\n\nPatients must have stage D2 prostate carcinoma or State D1 disease with a Gleason grade 7 or above (poorly differentiated).\n\nNo other malignancy except curatively treated basal cell cancer of the skin.\n\nPerformance status ECOG of 0-3.\n\nAbility to give informed consent.\n\nNo history of bleeding diathesis. Patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.\n\nNo history of cerebrovascular event, either thrombotic or hemorrhagic.\n\nNo current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. Patient cannot be on calcium channel blockers such as Nifedipine, Diltiazem, or Verapamil.\n\nNo clinical or radiographic evidence of brain metastases.\n\nPatients with extensive liver replacement (greater than 50%) by tumor will be ineligible.\n\nPatients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.\n\nPatients must have adequate hepatic function (bilirubin less than 1.5mg%).\n\nIf the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.\n\nPatients must not have received chemotherapy.\n\nAn absolute granulocyte count greater than 1,500; platelet count greater than 100,000; Fibrinogen greater than 200 mg/dl; Hgb greater than or equal to 9 gm/dl.\n\nReliability of the patient to take oral medication, go home and return for follow-up and treatment."}, "identificationModule"=>{"nctId"=>"NCT00001266", "briefTitle"=>"A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma", "orgStudyIdInfo"=>{"id"=>"910014"}, "secondaryIdInfos"=>[{"id"=>"91-C-0014"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Suramin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}
