Nctid:
NCT00001449
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D002955", "term"=>"Leucovorin"}, {"id"=>"D000093542", "term"=>"Gemcitabine"}, {"id"=>"D005467", "term"=>"Floxuridine"}], "ancestors"=>[{"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000931", "term"=>"Antidotes"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D014803", "term"=>"Vitamin B Complex"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}], "browseLeaves"=>[{"id"=>"M6191", "name"=>"Leucovorin", "asFound"=>"May", "relevance"=>"HIGH"}, {"id"=>"M2985", "name"=>"Gemcitabine", "asFound"=>"Used", "relevance"=>"HIGH"}, {"id"=>"M5381", "name"=>"Calcium", "relevance"=>"LOW"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}, {"id"=>"M29233", "name"=>"Levoleucovorin", "relevance"=>"LOW"}, {"id"=>"M8595", "name"=>"Floxuridine", "asFound"=>"double-J stent", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M4250", "name"=>"Antidotes", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-09", "completionDateStruct"=>{"date"=>"2000-04"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Anti-Cancer Agents", "Antimetabolite", "Palliation", "Pharmacodynamics", "Pharmacokinetics"], "conditions"=>["Neoplasms"]}, "referencesModule"=>{"references"=>[{"pmid"=>"3383195", "type"=>"BACKGROUND", "citation"=>"Heinemann V, Hertel LW, Grindey GB, Plunkett W. Comparison of the cellular pharmacokinetics and toxicity of 2',2'-difluorodeoxycytidine and 1-beta-D-arabinofuranosylcytosine. Cancer Res. 1988 Jul 15;48(14):4024-31."}, {"pmid"=>"1732039", "type"=>"BACKGROUND", "citation"=>"Heinemann V, Xu YZ, Chubb S, Sen A, Hertel LW, Grindey GB, Plunkett W. Cellular elimination of 2',2'-difluorodeoxycytidine 5'-triphosphate: a mechanism of self-potentiation. Cancer Res. 1992 Feb 1;52(3):533-9."}, {"pmid"=>"2233693", "type"=>"BACKGROUND", "citation"=>"Heinemann V, Xu YZ, Chubb S, Sen A, Hertel LW, Grindey GB, Plunkett W. Inhibition of ribonucleotide reduction in CCRF-CEM cells by 2',2'-difluorodeoxycytidine. Mol Pharmacol. 1990 Oct;38(4):567-72."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine the clinical toxicities associated with administering sequential dFdC as a one hour infusion followed by a continuous infusion of FUdR over 24 hours with low dose oral LV weekly for three weeks out of four.", "detailedDescription"=>"The MTD and biochemically active dose of FUDR as a 24-hour and gemcitabine as a 2-hour infusion will be determined first (Part A); if the biochemically active FUDR dose is less than the MTD, new patients will be entered to determine the maximum tolerated duration of FUDR infusion (Part B)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nDiagnostically proven locally advanced, but unresectable primary or recurrent solid tumors or lymphoma or metastatic solid tumors that have failed standard therapy or no such therapy is available.\n\nObjectively measurable disease not required.\n\nNo patients with leukemia or primary or metastatic CNS malignancies.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy: Greater than 4 weeks since prior immunotherapy and recovered from all toxic effects.\n\nChemotherapy: Greater than 4 weeks since prior chemotherapy and recovered from all toxic effects with following exceptions: At least 6 weeks since prior mitomycin C or nitrosourea therapy. At least 3 months since prior suramin therapy.\n\nEndocrine Therapy: Not specified\n\nRadiotherapy: At least 2 weeks since prior radiotherapy (4 weeks if at least 21% of marrow irradiated) and recovered from all toxic effects.\n\nSurgery: Recovered from any prior surgery.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0-2\n\nHematopoietic:\n\nAGC at least 2,000/microL.\n\nPlatelet count at least 100,000/microL.\n\nHepatic: Bilirubin no greater than 2.0 mg/dL.\n\nRenal: Creatinine no greater than 2.0 mg/dL.\n\nOTHER:\n\nNo failure of prior gemcitabine therapy.\n\nNo concurrent cimetidine (ranitidine and other anti-ulcer agents allowed).\n\nNo active infection requiring intravenous antibiotic therapy.\n\nHIV negative.\n\nNo other medical contraindication to protocol therapy.\n\nNo pregnant or nursing women.\n\nAdequate contraception required of fertile patients."}, "identificationModule"=>{"nctId"=>"NCT00001449", "briefTitle"=>"A Phase I Study of Weekly Gemcitabine in Combination With Infusional Fluorodeoxyuridine and Oral Calcium Leucovorin in Adult Cancer Patients", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase I Study of Weekly Gemcitabine in Combination With Infusional Fluorodeoxyuridine and Oral Calcium Leucovorin in Adult Cancer Patients", "orgStudyIdInfo"=>{"id"=>"950197"}, "secondaryIdInfos"=>[{"id"=>"95-C-0197"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"gemcitabine", "type"=>"DRUG"}, {"name"=>"fluorodeoxyuridine", "type"=>"DRUG"}, {"name"=>"leucovorin", "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"}}}}
