Nctid:
NCT00002562
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002583", "term"=>"Uterine Cervical Neoplasms"}, {"id"=>"D014625", "term"=>"Vaginal Neoplasms"}], "ancestors"=>[{"id"=>"D014594", "term"=>"Uterine Neoplasms"}, {"id"=>"D005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D002577", "term"=>"Uterine Cervical Diseases"}, {"id"=>"D014591", "term"=>"Uterine Diseases"}, {"id"=>"D005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D014623", "term"=>"Vaginal Diseases"}], "browseLeaves"=>[{"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M5830", "name"=>"Uterine Cervical Neoplasms", "asFound"=>"Cervical Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M20408", "name"=>"Adenocarcinoma, Clear Cell", "relevance"=>"LOW"}, {"id"=>"M17373", "name"=>"Vaginal Neoplasms", "asFound"=>"Vaginal Cancer", "relevance"=>"HIGH"}, {"id"=>"M17342", "name"=>"Uterine Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5825", "name"=>"Uterine Cervical Diseases", "relevance"=>"LOW"}, {"id"=>"M17339", "name"=>"Uterine Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "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"=>"M17371", "name"=>"Vaginal Diseases", "relevance"=>"LOW"}, {"id"=>"T5829", "name"=>"Vaginal Cancer", "asFound"=>"Vaginal Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D017239", "term"=>"Paclitaxel"}], "ancestors"=>[{"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M19537", "name"=>"Paclitaxel", "asFound"=>"Training", "relevance"=>"HIGH"}, {"id"=>"M231", "name"=>"Albumin-Bound Paclitaxel", "relevance"=>"LOW"}, {"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"=>{"type"=>"ESTIMATED", "count"=>25}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-03"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2005-12", "completionDateStruct"=>{"date"=>"2004-08", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-06-19", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-08-09", "lastUpdatePostDateStruct"=>{"date"=>"2013-06-20", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-08-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["recurrent cervical cancer", "recurrent vaginal cancer", "vaginal clear cell adenocarcinoma", "cervical adenocarcinoma"], "conditions"=>["Cervical Cancer", "Vaginal Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11230468", "type"=>"RESULT", "citation"=>"Curtin JP, Blessing JA, Webster KD, Rose PG, Mayer AR, Fowler WC Jr, Malfetano JH, Alvarez RD. Paclitaxel, an active agent in nonsquamous carcinomas of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2001 Mar 1;19(5):1275-8. doi: 10.1200/JCO.2001.19.5.1275."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.", "detailedDescription"=>"OBJECTIVES: I. Estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols. II. Determine the frequency and severity of observed adverse effects on this study.\n\nOUTLINE: Single-Agent Chemotherapy. Paclitaxel, TAX, NSC-673089.\n\nPROJECTED ACCRUAL: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. If more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. As of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina or cervix Documented disease progression after local therapy required Disease must be considered incurable Bidimensionally measurable disease required by physical examination or medical imaging\n\nPATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no more than 1.5 times normal AST no more than 3 times normal Alkaline phosphatase no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Other: Not eligible for a higher priority GOG protocol No significant infection No prior or concomitant second malignancy except nonmelanomatous skin cancer\n\nPRIOR CONCURRENT THERAPY: At least 3 weeks since therapy directed at malignancy Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen (either single or combination cytotoxic drug therapy) No prior paclitaxel Recovery from prior chemotherapy required Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent disease except a low dose, single fraction used to abrogate menorrhagia Recovery from prior radiotherapy required Surgery: Recovery from prior surgery required"}, "identificationModule"=>{"nctId"=>"NCT00002562", "briefTitle"=>"Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"EVALUATION OF PACLITAXEL (TAXOL) IN PERSISTENT OR RECURRENT NON-SQUAMOUS CELL CARCINOMA OF THE CERVIX AND VAGINA", "orgStudyIdInfo"=>{"id"=>"CDR0000063506"}, "secondaryIdInfos"=>[{"id"=>"GOG-128B"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"paclitaxel", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"University of Alabama Comprehensive Cancer Center", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"90033-0800", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC/Norris Comprehensive Cancer Center", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095-1781", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Jonsson Comprehensive Cancer Center, UCLA", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94304", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Women's Cancer Center", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"94305-5408", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Stanford University Medical Center", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"80262", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"University of Colorado Cancer Center", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Vincent T. 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Curtin, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Memorial Sloan Kettering Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gynecologic Oncology Group", "class"=>"NETWORK"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}]}}}
