Nctid:
NCT00001495
Payload:
{"FullStudy"=>{"Rank"=>473468, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000009369", "ConditionMeshTerm"=>"Neoplasms"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000077146", "InterventionMeshTerm"=>"Irinotecan"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000059004", "InterventionAncestorTerm"=>"Topoisomerase I Inhibitors"}, {"InterventionAncestorId"=>"D000059003", "InterventionAncestorTerm"=>"Topoisomerase Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M1671", "InterventionBrowseLeafName"=>"Irinotecan", "InterventionBrowseLeafAsFound"=>"Questionnaire", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5116", "InterventionBrowseLeafName"=>"Camptothecin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M29039", "InterventionBrowseLeafName"=>"Topoisomerase I Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"40"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"November 1995"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 1999", "CompletionDateStruct"=>{"CompletionDate"=>"October 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Camptothecin", "Cancer", "Chemotherapy", "Natural Products", "Neoplasms"]}, "ConditionList"=>{"Condition"=>["Neoplasms"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"1653362", "ReferenceType"=>"background", "ReferenceCitation"=>"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."}, {"ReferencePMID"=>"8044782", "ReferenceType"=>"background", "ReferenceCitation"=>"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"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "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"=>{"OrgClass"=>"NIH", "OrgFullName"=>"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"=>{"OrgStudyId"=>"960013"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"96-C-0013"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"irinotecan (CPT-11)", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}
