Nctid:
NCT00001450
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002289", "term"=>"Carcinoma, Non-Small-Cell Lung"}, {"id"=>"D000008175", "term"=>"Lung Neoplasms"}], "ancestors"=>[{"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}, {"id"=>"D000012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D000013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"Carcinoma, Non-Small-Cell Lung", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000017239", "term"=>"Paclitaxel"}, {"id"=>"D000002945", "term"=>"Cisplatin"}], "ancestors"=>[{"id"=>"D000000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000050257", "term"=>"Tubulin Modulators"}, {"id"=>"D000050256", "term"=>"Antimitotic Agents"}, {"id"=>"D000050258", "term"=>"Mitosis Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M19537", "name"=>"Paclitaxel", "asFound"=>"Training", "relevance"=>"HIGH"}, {"id"=>"M231", "name"=>"Albumin-Bound Paclitaxel", "relevance"=>"LOW"}, {"id"=>"M6182", "name"=>"Cisplatin", "asFound"=>"Health", "relevance"=>"HIGH"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>58}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-07", "completionDateStruct"=>{"date"=>"2000-06"}, "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"=>["Chemotherapy", "In Vitro Testing", "Infusional", "Lung Neoplasm", "Pharmacokinetics"], "conditions"=>["Carcinoma, Non-Small-Cell Lung", "Lung Neoplasms"]}, "descriptionModule"=>{"briefSummary"=>"This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC.", "detailedDescription"=>"This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC. In addition, the plasma levels of paclitaxel will be measured, and the in vitro paclitaxel chemosensitivity of the tumor cells from as many patients as possible will be determined. This will allow further study of the relationship between in vitro drug sensitivity, achievable plasma concentrations of paclitaxel, and patients' response to therapy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, Mixed histologies in the absence of a predominant small cell component.\n\nEligible Stages Include:\n\nStage IV, Stage IIIA/B ineligible for resection or radiotherapy, Postsurgical recurrence that is histologically or cytologically proven.\n\nCNS Metastases Allowed Provided:\n\nRadiotherapy completed prior to entry.\n\nNo requirement for concurrent steroids.\n\nNo carcinomatous meningitis.\n\nNo epidural metastases.\n\nMeasurable disease not required.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy: Not specified.\n\nChemotherapy: No prior chemotherapy for lung cancer.\n\nEndocrine Therapy: Not specified.\n\nRadiotherapy: No prior chest irradiation for lung cancer.\n\nSurgery: Prior surgery allowed.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance Status: ECOG 0-2.\n\nHematopoietic:\n\nAbsolute granulocyte count greater than 2,000.\n\nPlatelet count greater than 100,000.\n\nHepatic: Bilirubin no greater than 1.5 mg/dL.\n\nRenal: Creatinine no greater than 1.5 mg/dL.\n\nCardiovascular:\n\nNo CHF unless fully compensated.\n\nNo second- or third-degree heart block.\n\nNo uncontrolled, symptomatic atrial dysrhythmia except sinus bradycardia.\n\nNo sustained ventricular tachycardia.\n\nNo MI within 3 months.\n\nOTHER:\n\nNo uncontrolled infection unless due to an obstructed bronchus.\n\nNo major psychiatric problems requiring hospitalization.\n\nNo psychotropic medications such as phenothiazines.\n\nNo contraindication to transfusion, if required.\n\nNo second malignancy within 5 years except: Nonmelanomatous skin cancer.\n\nIn situ cervical cancer.\n\nNo pregnant or nursing women.\n\nEffective contraception required of fertile patients."}, "identificationModule"=>{"nctId"=>"NCT00001450", "briefTitle"=>"Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC", "orgStudyIdInfo"=>{"id"=>"950198"}, "secondaryIdInfos"=>[{"id"=>"95-C-0198"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"paclitaxel", "type"=>"DRUG"}, {"name"=>"cisplatin", "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"}}}}