Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 4:41 PM
Study NCT ID:
NCT00856050
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2009-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007890', 'term': 'Leiomyosarcoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sgeorge2@partners.org', 'phone': '617-632-5204', 'title': 'Dr. Suzanne George', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Letrozole', 'description': 'Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day', 'otherNumAtRisk': 26, 'otherNumAffected': 20, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea w/o prior colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Joint= pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle= pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival Rate at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole', 'description': 'letrozole 2.5mg by mouth per day'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Data below are reported as progression free rate (%).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Letrozole', 'description': 'Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Letrozole', 'description': 'letrozole 2.5mg by mouth per day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '74'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2009-03-04', 'resultsFirstSubmitDate': '2014-01-09', 'studyFirstSubmitQcDate': '2009-03-04', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-03', 'studyFirstPostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival Rate at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Data below are reported as progression free rate (%).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['estrogen receptor positive', 'progesterone receptor positive', 'letrozole'], 'conditions': ['Leiomyosarcoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine if letrozole is effective at controlling the growth or spread of estrogen and/or progesterone receptor positive uterine leiomyosarcoma. This drug has been used in research studies for other cancers and is currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone levels in the body, it may be helpful to control tumors that express hormone receptors ( ER/PR).', 'detailedDescription': '* Participants will take letrozole orally once a day. During the research study the following tests and procedures will be performed:\n* Visit 1 (Day 1): physical examination, vital signs and blood work\n* Visit 2 (Day 43): physical examination, vital signs, blood work, CT or MRI scan\n* Visit 3 (Day 85): physical examination, vital signs, blood work, CT or MRI scan\n* Participants will remain on the study drug as long as they do not have any serious sife effect and their disease does not get worse'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed, advanced estrogen (ER)/progesterone receptor (PR) positive leiomyosarcoma of uterine origin, for which standard multi-modality curative therapies do not exist or are no longer effective\n* Patients must be postmenopausal. Postmenopausal is defined as any of the following: 1)Bilateral oophorectomy 2) 60 years of age or older 3)Younger than 60 AND amenorrheic for 12 months or more AND follicle stimulating hormone (FSH) and estradiol (E2) within postmenopausal range 4)Ovarian ablation radiotherapy confirmed by FSH and estradiol (E2) level in the postmenopausal range\n* Evidence of ER and/or PR positivity, either in primary or secondary tumor tissue\n* Measurable disease outside of a prior irradiated area as defined by RECIST guidelines. A lesion in a previously irradiated area is not eligible for measurable diseae unless there is objective evidence of progression of the lesion prior to study enrollment\n* 18 years of age or older\n* Life expectancy of 3 months or more\n* ECOG Performance Status 0, 1, or 2\n* No limit to number of prior chemotherapies or biologics\n* Normal organ function as outlined in the protocol\n* Resolution of clinically significant toxicities related to prior therapies\n\nExclusion Criteria:\n\n* Pre-menopausal women\n* Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)\n* Palliative radiotherapy within 2 weeks of study entry\n* Major surgery within 2 weeks of study entry\n* Prior hormonal therapy for the treatment of uterine leiomyosarcoma (prior hormone replacement therapy is allowed)\n* Participants may not be receiving any other concomitant investigational agents\n* Uncontrolled brain or central nervous system metastases\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention'}, 'identificationModule': {'nctId': 'NCT00856050', 'briefTitle': 'Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Phase 2 Clinical Study of Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma', 'orgStudyIdInfo': {'id': '08-341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'letrozole', 'description': 'single arm trial - all patients received letrozole 2.5mg by mouth per day', 'interventionNames': ['Drug: letrozole']}], 'interventions': [{'name': 'letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'Taken orally once a day continuously', 'armGroupLabels': ['letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Suzanne George, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suzanne George, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}