Nctid:
NCT00001495
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009369", "term"=>"Neoplasms"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077146", "term"=>"Irinotecan"}], "ancestors"=>[{"id"=>"D000059004", "term"=>"Topoisomerase I Inhibitors"}, {"id"=>"D000059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M1671", "name"=>"Irinotecan", "asFound"=>"Use of", "relevance"=>"HIGH"}, {"id"=>"M5426", "name"=>"Camptothecin", "relevance"=>"LOW"}, {"id"=>"M29349", "name"=>"Topoisomerase I Inhibitors", "relevance"=>"LOW"}, {"id"=>"M29348", "name"=>"Topoisomerase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>40}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-11"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-09", "completionDateStruct"=>{"date"=>"2000-10"}, "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"=>["Camptothecin", "Cancer", "Chemotherapy", "Natural Products", "Neoplasms"], "conditions"=>["Neoplasms"]}, "referencesModule"=>{"references"=>[{"pmid"=>"1653362", "type"=>"BACKGROUND", "citation"=>"Negoro S, Fukuoka M, Masuda N, Takada M, Kusunoki Y, Matsui K, Takifuji N, Kudoh S, Niitani H, Taguchi T. Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst. 1991 Aug 21;83(16):1164-8. doi: 10.1093/jnci/83.16.1164."}, {"pmid"=>"8044782", "type"=>"BACKGROUND", "citation"=>"de Forni M, Bugat R, Chabot GG, Culine S, Extra JM, Gouyette A, Madelaine I, Marty ME, Mathieu-Boue A. Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res. 1994 Aug 15;54(16):4347-54."}]}, "descriptionModule"=>{"briefSummary"=>"This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.", "detailedDescription"=>"Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. The duration of these treatments will be escalated in our Phase I study until patients are receiving therapy for 2 out of every 3 weeks. Standard Phase I drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, SN-38 will also be examined. We will also attempt to monitor the intracellular molecular effects of SN-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nRecurrent or metastatic cancer, including lymphoma.\n\nNo leukemia.\n\nNo active CNS disease.\n\nRefractory to all effective therapy OR No effective therapy exists.\n\nMeasurable disease not required.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy: Greater than 4 weeks and recovered from immunotherapy.\n\nChemotherapy: Greater than 4 weeks and recovered from chemotherapy.\n\nPrevious therapy with irinotecan is permitted.\n\nEndocrine Therapy: Not specified.\n\nRadiotherapy: Greater than 4 weeks since radiotherapy.\n\nSurgery: Recovered from prior surgery.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0-2.\n\nHematopoietic: AGC greater than 1,500.\n\nPlatelets greater than 100,000.\n\nHepatic: Bilirubin no greater than 1.5 mg/dL.\n\nAST no greater than 2 times normal.\n\nRenal: Creatinine no greater than 1.5 mg/dL.\n\nOTHER:\n\nHIV negative.\n\nNo active infection requiring antibiotics.\n\nNo concurrent medical illness that would interfere with chemotherapy.\n\nNo pregnant or nursing women.\n\nAdequate contraception required of fertile patients.\n\nImaging/exams for tumor measurement within 28 days prior to registration."}, "identificationModule"=>{"nctId"=>"NCT00001495", "briefTitle"=>"A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors", "orgStudyIdInfo"=>{"id"=>"960013"}, "secondaryIdInfos"=>[{"id"=>"96-C-0013"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"irinotecan (CPT-11)", "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"}}}}
