Nctid:
NCT00001165
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000009362", "term"=>"Neoplasm Metastasis"}, {"id"=>"D000000236", "term"=>"Adenoma"}, {"id"=>"D000015043", "term"=>"Zollinger-Ellison Syndrome"}, {"id"=>"D000015408", "term"=>"Gastrinoma"}, {"id"=>"D000007516", "term"=>"Adenoma, Islet Cell"}, {"id"=>"D000013577", "term"=>"Syndrome"}], "ancestors"=>[{"id"=>"D000004194", "term"=>"Disease"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000009385", "term"=>"Neoplastic Processes"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009384", "term"=>"Paraneoplastic Endocrine Syndromes"}, {"id"=>"D000010257", "term"=>"Paraneoplastic Syndromes"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000010437", "term"=>"Peptic Ulcer"}, {"id"=>"D000004378", "term"=>"Duodenal Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000013272", "term"=>"Stomach Diseases"}, {"id"=>"D000018273", "term"=>"Carcinoma, Islet Cell"}, {"id"=>"D000000230", "term"=>"Adenocarcinoma"}, {"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000010190", "term"=>"Pancreatic Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D000010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M13110", "name"=>"Pancreatic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M3591", "name"=>"Adenoma", "asFound"=>"Adenoma", "relevance"=>"HIGH"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "asFound"=>"Neoplasm Metastasis", "relevance"=>"HIGH"}, {"id"=>"M10548", "name"=>"Adenoma, Islet Cell", "asFound"=>"Islet Cell Adenoma", "relevance"=>"HIGH"}, {"id"=>"M18083", "name"=>"Gastrinoma", "asFound"=>"Zollinger-Ellison Syndrome", "relevance"=>"HIGH"}, {"id"=>"M17778", "name"=>"Zollinger-Ellison Syndrome", "asFound"=>"Zollinger-Ellison Syndrome", "relevance"=>"HIGH"}, {"id"=>"M12330", "name"=>"Neoplastic Processes", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M13170", "name"=>"Paraneoplastic Syndromes", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M17206", "name"=>"Ulcer", "relevance"=>"LOW"}, {"id"=>"M13348", "name"=>"Peptic Ulcer", "relevance"=>"LOW"}, {"id"=>"M7552", "name"=>"Duodenal Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M16062", "name"=>"Stomach Diseases", "relevance"=>"LOW"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M20418", "name"=>"Carcinoma, Islet Cell", "relevance"=>"LOW"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"T4387", "name"=>"Pancreatic Cancer", "relevance"=>"LOW"}, {"id"=>"T4389", "name"=>"Pancreatic Neuroendocrine Tumor", "asFound"=>"Islet Cell Adenoma", "relevance"=>"HIGH"}, {"id"=>"T6029", "name"=>"Zollinger-Ellison Syndrome", "asFound"=>"Zollinger-Ellison Syndrome", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000004317", "term"=>"Doxorubicin"}, {"id"=>"D000013311", "term"=>"Streptozocin"}, {"id"=>"D000005472", "term"=>"Fluorouracil"}], "ancestors"=>[{"id"=>"D000000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D000059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M8600", "name"=>"Fluorouracil", "asFound"=>"Outcomes", "relevance"=>"HIGH"}, {"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Received", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "relevance"=>"LOW"}, {"id"=>"M22554", "name"=>"Pancrelipase", "relevance"=>"LOW"}, {"id"=>"M13114", "name"=>"Pancreatin", "relevance"=>"LOW"}, {"id"=>"M16101", "name"=>"Streptozocin", "asFound"=>"DRG-0012", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M29348", "name"=>"Topoisomerase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>999}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1978-09"}, "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"=>["Gastrinoma", "Acid Secretion", "Toxicity"], "conditions"=>["Islet Cell Adenoma", "Neoplasm Metastasis", "Zollinger Ellison Syndrome"]}, "referencesModule"=>{"references"=>[{"pmid"=>"3309661", "type"=>"BACKGROUND", "citation"=>"Wolfe MM, Jensen RT. Zollinger-Ellison syndrome. Current concepts in diagnosis and management. N Engl J Med. 1987 Nov 5;317(19):1200-9. doi: 10.1056/NEJM198711053171907."}, {"pmid"=>"6284361", "type"=>"BACKGROUND", "citation"=>"Moertel CG, Lavin PT, Hahn RG. Phase II trial of doxorubicin therapy for advanced islet cell carcinoma. Cancer Treat Rep. 1982 Jul;66(7):1567-9."}, {"pmid"=>"4352784", "type"=>"BACKGROUND", "citation"=>"Broder LE, Carter SK. Pancreatic islet cell carcinoma. II. Results of therapy with streptozotocin in 52 patients. Ann Intern Med. 1973 Jul;79(1):108-18. doi: 10.7326/0003-4819-79-1-108. No abstract available."}]}, "descriptionModule"=>{"briefSummary"=>"Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors.\n\nPrior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers. Because of such effective drugs to treat the ulcers it is more common to see patients dying due to the pancreatic tumors.\n\nThe study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin.", "detailedDescription"=>"Heretofore morbidity and risk of death in Zollinger-Ellison syndrome were caused by severe ulcer disease. The advent of specific drugs to cure ulcer disease now extends life until metastases from the non-beta-islet cell tumor cause death. The present study proposes to continue to test the effect of combined chemotherapy with streptozotocin, 5-fluorouracil and doxorubicin in biopsy-proven cases of metastatic non-beta-islet cell tumor in patients with Zollinger-Ellison syndrome. We published our initial experience with this protocol in 1988. An objective response was observed in 40% of patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"INCLUSION CRITERIA\n\nSubjects selected for this study will be patients with Zollinger-Ellison syndrome who are being evaluated under the protocol entitled \"Diagnostic Evaluation of Patients with Suspected Abnormalities of Gastric Secretion\" (80-DK-0123).\n\nHistologically proven gastrinoma;\n\nEvidence of metastatic disease or locally invasive tumor by angiography, ultrasound, computerized axial tomography, MRI scan or bone scan;\n\nProgression of the tumor during the preceding 6 months.\n\nEXCLUSION CRITERIA\n\nThe following pre-existing conditions will exclude patients from the study:\n\nCongestive heart failure;\n\nProteinuria greater than 1 gram/day;\n\nSerum creatinine greater than 1.5 mg%;\n\nPlatelet count less than 100,000/mm3;\n\nWhite blood count less than 2500/mm3;\n\nPregnancy."}, "identificationModule"=>{"nctId"=>"NCT00001165", "briefTitle"=>"Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Evaluation of Chemotherapy With Streptozotocin Combined With 5-Fluorouracil and Adriamycin in Patients With Zollinger-Ellison Syndrome and Metastatic Non-Beta-Islet Cell Neoplasm", "orgStudyIdInfo"=>{"id"=>"780133"}, "secondaryIdInfos"=>[{"id"=>"78-DK-0133"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "class"=>"NIH"}}}}
