Nctid:
NCT00001427
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010051", "term"=>"Ovarian Neoplasms"}], "ancestors"=>[{"id"=>"D000004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000010049", "term"=>"Ovarian Diseases"}, {"id"=>"D000000291", "term"=>"Adnexal Diseases"}, {"id"=>"D000005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000006058", "term"=>"Gonadal Disorders"}], "browseLeaves"=>[{"id"=>"M12974", "name"=>"Ovarian Neoplasms", "asFound"=>"Ovarian Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M1704", "name"=>"Carcinoma, Ovarian Epithelial", "relevance"=>"LOW"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12972", "name"=>"Ovarian Diseases", "relevance"=>"LOW"}, {"id"=>"M3643", "name"=>"Adnexal Diseases", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M9163", "name"=>"Gonadal Disorders", "relevance"=>"LOW"}, {"id"=>"T4352", "name"=>"Ovarian Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"T4354", "name"=>"Ovarian Epithelial Cancer", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000080125", "term"=>"9-aminocamptothecin"}], "ancestors"=>[{"id"=>"D000000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M19537", "name"=>"Paclitaxel", "relevance"=>"LOW"}, {"id"=>"M6182", "name"=>"Cisplatin", "relevance"=>"LOW"}, {"id"=>"M231", "name"=>"Albumin-Bound Paclitaxel", "relevance"=>"LOW"}, {"id"=>"M212342", "name"=>"9-aminocamptothecin", "asFound"=>"Ursofalk", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>40}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-01"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-01", "completionDateStruct"=>{"date"=>"2000-04"}, "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"=>["Pharmacodynamic Studies", "Pharmacokinetics"], "conditions"=>["Ovarian Neoplasms"]}, "referencesModule"=>{"references"=>[{"pmid"=>"1334279", "type"=>"BACKGROUND", "citation"=>"Burris HA, Rothenberg ML, Kuhn JG, Von Hoff DD. Clinical trials with the topoisomerase I inhibitors. Semin Oncol. 1992 Dec;19(6):663-9."}, {"pmid"=>"1309380", "type"=>"BACKGROUND", "citation"=>"Fukuoka M, Niitani H, Suzuki A, Motomiya M, Hasegawa K, Nishiwaki Y, Kuriyama T, Ariyoshi Y, Negoro S, Masuda N, et al. A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer. J Clin Oncol. 1992 Jan;10(1):16-20. doi: 10.1200/JCO.1992.10.1.16."}]}, "descriptionModule"=>{"briefSummary"=>"The objectives of this study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.", "detailedDescription"=>"This is a Phase II study of 9-aminocamptothecin (9-AC), administered as an intravenous continuous infusion over 72 hours with G-CSF support for patients with advanced refractory ovarian cancer. The objectives of the present study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically proven, advanced epithelial ovarian cancer.\n\nHistologic confirmation by Pathology Department, NIH, required.\n\nRecurrent disease after paclitaxel and either cisplatin or carboplatin. Combination platinum/paclitaxel acceptable.\n\nBidimensionally measurable disease on physical exam, radiographs, or peritoneoscopy. Repeat peritoneoscopy after 8 courses of therapy required if documentation of disease was solely by peritoneoscopy.\n\nLaparotomy not required.\n\nNo CNS metastasis.\n\nNo borderline or mixed histology.\n\nPRIOR/CONCURRENT THERAPY:\n\nSee Disease Characteristics.\n\nMore than 4 weeks since any prior therapy and recovered.\n\nNo prior camptothecin analogue-based chemotherapy.\n\nNo prior radiotherapy except intraperitoneal 32-P.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0-2.\n\nHematopoietic:\n\nWBC greater than 3,000.\n\nAGC greater than 1,500.\n\nPlatelets at least 100,000.\n\nHemoglobin greater than 9 g/dL OR;\n\nHematocrit greater than 27 g/dL.\n\nHepatic:\n\nBilirubin no greater than 1.5 mg/dL.\n\nSerum transaminases no greater than 2 times normal.\n\nRenal:\n\n24-hour creatinine clearance greater than 45 mL/min (documented by NCI investigator or primary care physician).\n\nCardiovascular:\n\nNo myocardial infarction within 12 months.\n\nNo active congestive heart failure.\n\nNo heart block.\n\nNo arrhythmia requiring medication.\n\nOTHER:\n\nNo active uncontrolled infection.\n\nNo known HIV positivity.\n\nNo second malignancy currently under treatment except: Local basal cell carcinoma of the skin, Cervical carcinoma in situ, Other malignancies (e.g., stage I breast cancer) eligible at the discretion of the principal or associate investigators.\n\nNo pregnant women."}, "identificationModule"=>{"nctId"=>"NCT00001427", "briefTitle"=>"A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin", "orgStudyIdInfo"=>{"id"=>"950056"}, "secondaryIdInfos"=>[{"id"=>"95-C-0056"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"9-aminocamptothecin", "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"}}}}
