Nctid:
NCT00001576
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D015179", "term"=>"Colorectal Neoplasms"}, {"id"=>"D009362", "term"=>"Neoplasm Metastasis"}, {"id"=>"D008113", "term"=>"Liver Neoplasms"}], "ancestors"=>[{"id"=>"D007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D003108", "term"=>"Colonic Diseases"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}, {"id"=>"D012002", "term"=>"Rectal Diseases"}, {"id"=>"D009385", "term"=>"Neoplastic Processes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D008107", "term"=>"Liver Diseases"}], "browseLeaves"=>[{"id"=>"M17890", "name"=>"Colorectal Neoplasms", "asFound"=>"Colorectal Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M8464", "name"=>"Fever", "relevance"=>"LOW"}, {"id"=>"M2454", "name"=>"Hyperthermia", "relevance"=>"LOW"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "asFound"=>"Neoplasm Metastasis", "relevance"=>"HIGH"}, {"id"=>"M11113", "name"=>"Liver Neoplasms", "asFound"=>"Liver Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "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"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}, {"id"=>"M12330", "name"=>"Neoplastic Processes", "relevance"=>"LOW"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D002955", "term"=>"Leucovorin"}, {"id"=>"D008558", "term"=>"Melphalan"}, {"id"=>"D005467", "term"=>"Floxuridine"}], "ancestors"=>[{"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"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}], "browseLeaves"=>[{"id"=>"M6191", "name"=>"Leucovorin", "asFound"=>"May", "relevance"=>"HIGH"}, {"id"=>"M11541", "name"=>"Melphalan", "asFound"=>"Experience", "relevance"=>"HIGH"}, {"id"=>"M11110", "name"=>"Liver Extracts", "relevance"=>"LOW"}, {"id"=>"M8595", "name"=>"Floxuridine", "asFound"=>"mTOR", "relevance"=>"HIGH"}, {"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"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "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"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>28}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-07"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2002-03", "completionDateStruct"=>{"date"=>"2002-03"}, "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"=>["Regional Therapy", "Organ Perfusion", "Metastases", "Hyperthermia"], "conditions"=>["Colorectal Neoplasm", "Liver Neoplasm", "Neoplasm Metastasis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7964942", "type"=>"BACKGROUND", "citation"=>"Kemeny N, Conti JA, Cohen A, Campana P, Huang Y, Shi WJ, Botet J, Pulliam S, Bertino JR. Phase II study of hepatic arterial floxuridine, leucovorin, and dexamethasone for unresectable liver metastases from colorectal carcinoma. J Clin Oncol. 1994 Nov;12(11):2288-95. doi: 10.1200/JCO.1994.12.11.2288."}, {"pmid"=>"8313315", "type"=>"BACKGROUND", "citation"=>"Kemeny N, Seiter K, Conti JA, Cohen A, Bertino JR, Sigurdson ER, Botet J, Chapman D, Mazumdar M, Budd AJ. Hepatic arterial floxuridine and leucovorin for unresectable liver metastases from colorectal carcinoma. New dose schedules and survival update. Cancer. 1994 Feb 15;73(4):1134-42. doi: 10.1002/1097-0142(19940215)73:43.0.co;2-v."}, {"pmid"=>"2961314", "type"=>"BACKGROUND", "citation"=>"Chang AE, Schneider PD, Sugarbaker PH, Simpson C, Culnane M, Steinberg SM. A prospective randomized trial of regional versus systemic continuous 5-fluorodeoxyuridine chemotherapy in the treatment of colorectal liver metastases. Ann Surg. 1987 Dec;206(6):685-93. doi: 10.1097/00000658-198712000-00001."}]}, "descriptionModule"=>{"briefSummary"=>"Patients with unresectable metastatic colorectal cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) with escalating dose melphalan. Postoperatively, patients will be treated with hepatic arterial infusion of floxuridine (FUDR), 0.2 mg/kg/day and leucovorin (LV), 15 mg/M2/day as a 2-week continuous infusion regimen. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.", "detailedDescription"=>"Patients with unresectable metastatic colorectal cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) with escalating dose melphalan. Postoperatively, patients will be treated with hepatic arterial infusion of floxuridine (FUDR), 0.2 mg/kg/day and leucovorin (LV), 15 mg/M(2)/day as a 2-week continuous infusion regimen. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Histologically or cytologically proven measurable metastatic colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies. Limited resectable extrahepatic disease is acceptable.\n\nPatients must not have been previously treated with intrahepatic artery infusional therapy using FUDR.\n\nPatients mush have had no chemotherapy, radiotherapy or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects.\n\nPatients must have an ECOG performance standard of 0, 1 or 2 on the day prior to treatment.\n\nPatients must have adequate hepatic function as evidence by bilirubin less than 2.0 and a PT and PTT that are within 1-2 seconds of the upper normal limit.\n\nPatients must not have biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies.\n\nPatients must not have a history of congestive heart failure with an LVEF less than 40%.\n\nPatients must not have COPD or other chronic pulmonary disease with PFT's less than 50% predicted for age.\n\nPatients must be 18 years of age or older.\n\nPatients must have a platelet count greater than 100,000 a Hct greater than 27.0, a white blood count greater than 3000/micro liters, and a creatinine less than or equal to 1.5 or a creatinine clearance of greater than 60 ml/min.\n\nPatients must not be pregnant or nursing.\n\nPatients must not be taking immunosuppressive drugs or on chronic anticoagulation.\n\nPatients must not have an active infection.\n\nPatients must not have severe allergic reactions to iodine contrast which can not be controlled by premedication with antihistamines and steroids.\n\nPatients must not have HIV disease.\n\nPatients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks. The patient must be willing to sign an informed consent."}, "identificationModule"=>{"nctId"=>"NCT00001576", "briefTitle"=>"A Phase I Study of Isolated Hepatic Perfusion With Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase I Study of Isolated Hepatic Perfusion With Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver", "orgStudyIdInfo"=>{"id"=>"970111"}, "secondaryIdInfos"=>[{"id"=>"97-C-0111"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Melphalan", "type"=>"DRUG"}, {"name"=>"Floxuridine", "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"}}}}
