Nctid:
NCT00001428
Payload:
{"FullStudy"=>{"Rank"=>474236, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000015179", "ConditionMeshTerm"=>"Colorectal Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007414", "ConditionAncestorTerm"=>"Intestinal Neoplasms"}, {"ConditionAncestorId"=>"D000005770", "ConditionAncestorTerm"=>"Gastrointestinal Neoplasms"}, {"ConditionAncestorId"=>"D000004067", "ConditionAncestorTerm"=>"Digestive System Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000004066", "ConditionAncestorTerm"=>"Digestive System Diseases"}, {"ConditionAncestorId"=>"D000005767", "ConditionAncestorTerm"=>"Gastrointestinal Diseases"}, {"ConditionAncestorId"=>"D000003108", "ConditionAncestorTerm"=>"Colonic Diseases"}, {"ConditionAncestorId"=>"D000007410", "ConditionAncestorTerm"=>"Intestinal Diseases"}, {"ConditionAncestorId"=>"D000012002", "ConditionAncestorTerm"=>"Rectal Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M17580", "ConditionBrowseLeafName"=>"Colorectal Neoplasms", "ConditionBrowseLeafAsFound"=>"Colorectal Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10138", "ConditionBrowseLeafName"=>"Intestinal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8576", "ConditionBrowseLeafName"=>"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6946", "ConditionBrowseLeafName"=>"Digestive System Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8573", "ConditionBrowseLeafName"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6945", "ConditionBrowseLeafName"=>"Digestive System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6026", "ConditionBrowseLeafName"=>"Colonic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10134", "ConditionBrowseLeafName"=>"Intestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14534", "ConditionBrowseLeafName"=>"Rectal Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Digestive System Diseases", "ConditionBrowseBranchAbbrev"=>"BC06"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000005472", "InterventionMeshTerm"=>"Fluorouracil"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000964", "InterventionAncestorTerm"=>"Antimetabolites, Antineoplastic"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000007166", "InterventionAncestorTerm"=>"Immunosuppressive Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M5071", "InterventionBrowseLeafName"=>"Calcium", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8290", "InterventionBrowseLeafName"=>"Fluorouracil", "InterventionBrowseLeafAsFound"=>"Primary", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5881", "InterventionBrowseLeafName"=>"Leucovorin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10097", "InterventionBrowseLeafName"=>"Interferons", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M18933", "InterventionBrowseLeafName"=>"Interferon-alpha", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M1685", "InterventionBrowseLeafName"=>"Interferon alpha-2", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5088", "InterventionBrowseLeafName"=>"Calcium, Dietary", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M28923", "InterventionBrowseLeafName"=>"Levoleucovorin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9902", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T447", "InterventionBrowseLeafName"=>"Folinic Acid", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}, {"InterventionBrowseBranchName"=>"Vitamins", "InterventionBrowseBranchAbbrev"=>"Vi"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"65"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"February 1995"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2000", "CompletionDateStruct"=>{"CompletionDate"=>"December 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"=>["Chemotherapy", "Cytokine", "Efficacy", "Palliation", "Solid Tumor"]}, "ConditionList"=>{"Condition"=>["Colorectal Neoplasms"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"6187435", "ReferenceType"=>"background", "ReferenceCitation"=>"Miyoshi T, Ogawa S, Kanamori T, Nobuhara M, Namba M. Interferon potentiates cytotoxic effects of 5-fluorouracil on cell proliferation of established human cell lines originating from neoplastic tissues. Cancer Lett. 1983 Jan;17(3):239-47. doi: 10.1016/0304-3835(83)90160-x."}, {"ReferencePMID"=>"6436183", "ReferenceType"=>"background", "ReferenceCitation"=>"Le J, Yip YK, Vilcek J. Cytolytic activity of interferon-gamma and its synergism with 5-fluorouracil. Int J Cancer. 1984 Oct 15;34(4):495-500. doi: 10.1002/ijc.2910340411."}, {"ReferencePMID"=>"2457431", "ReferenceType"=>"background", "ReferenceCitation"=>"Elias L, Crissman HA. Interferon effects upon the adenocarcinoma 38 and HL-60 cell lines: antiproliferative responses and synergistic interactions with halogenated pyrimidine antimetabolites. Cancer Res. 1988 Sep 1;48(17):4868-73."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This protocol will evaluate the activity of 5-Fluorouracil (FUra) given as a 1 hour infusion in combination with leucovorin (LV) and interferon IFN alpha-2a in patients with advanced, measurable colorectal cancer.", "DetailedDescription"=>"This protocol will evaluate the activity of 5-Fluorouracil (FUra) given as a 1 hour infusion in combination with leucovorin (LV) and interferon IFN alpha-2a in patients with advanced, measurable colorectal cancer. IFN alpha-2a will be given at 5 million U/m(2) SC days 1-6; LV, 200 mg/m(2), will be given as a short infusion over 30 minutes days 2-6, followed immediately by a 1 hour IV infusion of FUra days 2-6. The starting dose of FUra will be 425 mg/m(2)/d(1). Cycles will be repeated at three week intervals provided that the granulocyte count and platelet count have recovered to >e; 1200/microL and >e; 80,000/microL, respectively, and all non-hematologic toxicity has resolved. The dose of FUra will be adjusted according to individual tolerance. Preliminary experience with FUra given as a 1 hour infusion suggests that it is less toxic. The primary goal of this study is to determine if this less toxic regimen retains clinical antitumor activity. FUra plasma samples will be obtained the initial cycle at 50 and 55 minutes during the first 1 hour infusion of FUra to permit documentation of achieved plasma levels and to permit correlation between FUra pharmacokinetics and clinical toxicity and/or response. Pharmacokinetic sampling will be repeated if the dose of FUra is increased or decreased in subsequent cycles.\n\nPatients will be stratified according to whether or not they have received prior adjuvant chemotherapy. A two-stage design will be employed for patients with no prior chemotherapy: If less than or equal to 4 responses are seen among the initial 20 previously untreated patients, accrual will cease. If greater than or equal to 5 responses are seen in the initial 20 patients, however, accrual will be expanded to 40 patients.\n\nFourteen patients who have received prior adjuvant chemotherapy (completing it at least 6 months prior to study entry) or have received prior FUra only as a radiation sensitizer will be entered. If no responses are seen, accrual to this cohort will cease. If greater than or equal to 1 response is seen, accrual may be expanded to 24 patients."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nUnresectable primary colorectal adenocarcinoma that is metastatic or recurrent.\n\nObjectively measurable disease required.\n\nNo cerebral metastases.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy:\n\nNo history of intolerance to interferon alfa (IFN-A).\n\nAt least 4 weeks since immunotherapy and recovered.\n\nChemotherapy: No prior chemotherapy for metastatic or recurrent disease. At least 6 months since adjuvant chemotherapy with fluorouracil (5-FU) in combination with levamisole, leucovorin (CF), or IFN-A Interval waived for 5-FU (with or without CF) as a radiosensitizer only . No dose-limiting toxicity with prior 5-FU.\n\nEndocrine Therapy: Not specified\n\nRadiotherapy: At least 2 weeks since palliative radiotherapy and recovered. Prior definitive pelvic or whole or upper abdominal radiotherapy allowed in the absence of current radiation enteritis.\n\nSurgery: Prior surgery allowed with adequate healing/recovery\n\nPatient Characteristics:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0 or 1.\n\nHematopoietic:\n\nAGC at least 2,000.\n\nPlatelets at least 100,000.\n\nHepatic: Bilirubin no greater than 2.0 mg/dL\n\nRenal: Creatinine no greater than 2.0 mg/dL\n\nCardiovascular:\n\nNo MI within the past year.\n\nNo active ischemic heart disease.\n\nNo NYHA class III/IV status.\n\nNo symptomatic arrhythmia.\n\nOTHER:\n\nNo requirement for pharmacologic steroid doses for inflammatory or autoimmune disorders. Physiologic replacement doses of steroids allowed.\n\nNo concurrent cimetidine or oxypurinol.\n\nNo HIV antibody.\n\nNo history of seizure disorder.\n\nNo active infection or other serious concurrent medical illness that would preclude treatment.\n\nNo second malignancy within 3 years except curatively treated: In situ carcinoma of cervix, Basal cell carcinoma of the skin.\n\nNo pregnant or nursing women.\n\nEffective contraception required of fertile patients."}, "IdentificationModule"=>{"NCTId"=>"NCT00001428", "BriefTitle"=>"A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination With Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal Cancer", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination With Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal Cancer", "OrgStudyIdInfo"=>{"OrgStudyId"=>"950067"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"95-C-0067"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"5-fluorouracil", "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"}}}}}}