Nctid:
NCT00002465
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001943", "term"=>"Breast Neoplasms"}, {"id"=>"D016889", "term"=>"Endometrial Neoplasms"}, {"id"=>"D008654", "term"=>"Mesothelioma"}, {"id"=>"D000086002", "term"=>"Mesothelioma, Malignant"}], "ancestors"=>[{"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D001941", "term"=>"Breast Diseases"}, {"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D014594", "term"=>"Uterine Neoplasms"}, {"id"=>"D005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"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"=>"D000236", "term"=>"Adenoma"}, {"id"=>"D009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D018301", "term"=>"Neoplasms, Mesothelial"}, {"id"=>"D008175", "term"=>"Lung Neoplasms"}, {"id"=>"D012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D010997", "term"=>"Pleural Neoplasms"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M11634", "name"=>"Mesothelioma", "asFound"=>"Mesothelioma", "relevance"=>"HIGH"}, {"id"=>"M2537", "name"=>"Mesothelioma, Malignant", "asFound"=>"Mesothelioma", "relevance"=>"HIGH"}, {"id"=>"M19235", "name"=>"Endometrial Neoplasms", "asFound"=>"Endometrial Cancer", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M17342", "name"=>"Uterine Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "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"=>"M3591", "name"=>"Adenoma", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M20445", "name"=>"Neoplasms, Mesothelial", "relevance"=>"LOW"}, {"id"=>"M11172", "name"=>"Lung Neoplasms", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M13887", "name"=>"Pleural Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"T3584", "name"=>"Malignant Mesothelioma", "asFound"=>"Malignant Mesothelioma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D008535", "term"=>"Megestrol"}, {"id"=>"D019290", "term"=>"Megestrol Acetate"}], "ancestors"=>[{"id"=>"D003278", "term"=>"Contraceptives, Oral, Hormonal"}, {"id"=>"D003276", "term"=>"Contraceptives, Oral"}, {"id"=>"D003271", "term"=>"Contraceptive Agents, Female"}, {"id"=>"D003270", "term"=>"Contraceptive Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000080066", "term"=>"Contraceptive Agents, Hormonal"}, {"id"=>"D003280", "term"=>"Contraceptives, Oral, Synthetic"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019167", "term"=>"Appetite Stimulants"}, {"id"=>"D000697", "term"=>"Central Nervous System Stimulants"}], "browseLeaves"=>[{"id"=>"M11518", "name"=>"Megestrol", "asFound"=>"Bolus dose", "relevance"=>"HIGH"}, {"id"=>"M21272", "name"=>"Megestrol Acetate", "asFound"=>"Satiety", "relevance"=>"HIGH"}, {"id"=>"M6494", "name"=>"Contraceptive Agents", "relevance"=>"LOW"}, {"id"=>"M6500", "name"=>"Contraceptives, Oral", "relevance"=>"LOW"}, {"id"=>"M6502", "name"=>"Contraceptives, Oral, Hormonal", "relevance"=>"LOW"}, {"id"=>"M6495", "name"=>"Contraceptive Agents, Female", "relevance"=>"LOW"}, {"id"=>"M2116", "name"=>"Contraceptive Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M4029", "name"=>"Central Nervous System Stimulants", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1", "PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"UNKNOWN", "lastKnownStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"1987-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2007-07", "lastUpdateSubmitDate"=>"2013-11-05", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-07-16", "lastUpdatePostDateStruct"=>{"date"=>"2013-11-06", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-07-19", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["stage IV breast cancer", "recurrent breast cancer", "advanced malignant mesothelioma", "recurrent malignant mesothelioma", "stage IV endometrial carcinoma", "recurrent endometrial carcinoma"], "conditions"=>["Breast Cancer", "Endometrial Cancer", "Malignant Mesothelioma"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Some hormones can stimulate the growth of some types of cancer cells. Hormone therapy using megestrol may fight cancer by reducing the production of these hormones.\n\nPURPOSE: Phase I/II trial to study the effectiveness of high-dose megestrol in treating patients with metastatic breast cancer, endometrial cancer, or mesothelioma which cannot be treated with surgery or radiation therapy.", "detailedDescription"=>"OBJECTIVES: I. Evaluate the clinical effects of high-dose oral megestrol in improving regression rate and prolonging survival in patients with breast or endometrial carcinoma or mesothelioma. II. Evaluate the immune, endocrine, and clinical effects of this regimen, with particular attention to effects on cachexia.\n\nOUTLINE: This is a randomized study. Patients are stratified by performance status, dominant site of disease, and prior treatment with megestrol. Breast cancer patients are randomized to one of 3 doses of oral megestrol (800, 1,280, or 1,600 mg/day, divided qid). Female patients with other tumor types are nonrandomly assigned to receive oral megestrol at 1,600 mg/day. Male patients are nonrandomly assigned to a dose-finding study of megestrol. The first patient cohort receives megestrol at 480 mg/day in 3 divided doses, with further escalation for subsequent cohorts as tolerated. All patients continue therapy for at least 8 weeks, with treatment discontinued upon progression. Measurable lesions are evaluated every 2 months.\n\nPROJECTED ACCRUAL: 9 evaluable breast cancer patients at each dose level will be entered; 14 patients will be required for each of the other disease categories. (As of 11/92, the study is temporarily closed to patients with prostate cancer.)"}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically documented metastatic breast or endometrial carcinoma or mesothelioma not amenable to surgical and/or radiotherapeutic cure or long-term control Measurable soft tissue, bony, or visceral lesions required Indicator lesions other than blastic bony metastases and pleural effusions required for breast cancer Hormone receptor status (breast cancer): Estrogen-receptor-positive and/or progesterone-receptor-positive\n\nPATIENT CHARACTERISTICS: Age: At least 18 Sex (breast cancer): Not specified Menopausal status (breast cancer): Any status Performance status: Not specified Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since therapy Chemotherapy: At least 4 weeks since therapy Endocrine therapy: Breast cancer: At least disease stabilization achieved following tamoxifen or other hormonal manipulation if such treatment given previously At least 4 weeks since therapy Nonbreast cancer patients may be entered immediately after conventional doses of megestrol or other hormones Radiotherapy: At least 4 weeks since therapy Concomitant radiotherapy to nonindicator lesions allowed Surgery: At least 4 weeks since therapy"}, "identificationModule"=>{"nctId"=>"NCT00002465", "briefTitle"=>"High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or Mesothelioma", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"Phase I/II Study of High-Dose Megestrol in Breast or Endometrial Carcinoma or Mesothelioma", "orgStudyIdInfo"=>{"id"=>"CDR0000076422"}, "secondaryIdInfos"=>[{"id"=>"SVMC-V89-0296"}, {"id"=>"NCI-V89-0296"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"megestrol acetate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90057", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"St. Vincent Medical Center - Los Angeles", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}], "overallOfficials"=>[{"name"=>"Charles L. Wiseman, MD, FACP", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"St. Vincent Medical Center - Los Angeles", "class"=>"OTHER"}}}}
