Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00006903
Status:
UNKNOWN
Last Update Posted:
2019-03-20
First Post:
2000-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mleventhal@gogstats.org', 'phone': '716-845-4030', 'title': 'Melissa Leventhal', 'organization': 'NRG Oncology, Statistics and Data Management Center, Buffalo Office'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Accrual was discontinued after completion of the first stage of accrual due to lack of study drug activity.'}}, 'adverseEventsModule': {'timeFrame': 'Study treatment, and up to 30 days after stopping study treatment.', 'description': 'The frequencies of maximum grade of serious adverse event or, for other adverse events, treatment-related adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.\n\nOther Adverse Events reported are Grade 2 or higher.', 'eventGroups': [{'id': 'EG000', 'title': 'Faslodex', 'description': 'Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy.\n\nIncludes both Estrogen Receptor Positive and Estrogen Receptor Negative participants.', 'otherNumAtRisk': 53, 'otherNumAffected': 28, 'seriousNumAtRisk': 53, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constitutional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot Flashes/Flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection/Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ocular/Visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Death no ctcae term - disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death no ctcae term - death nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, gi - small bowel nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, gi - stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage/pulmonary - respiratory tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: abdominal pain nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estrogen Receptor Negative', 'description': 'Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy'}, {'id': 'OG001', 'title': 'Estrogen Receptor Positive', 'description': 'Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Disease Progression', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.', 'description': 'Primary outcome measured according to RECIST v1.0 Best Response:\n\nComplete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart\n\nDisease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.\n\nPartial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required\n\nStable Disease is any condition not meeting the above criteria.\n\nIndeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number eligible and treated participants within groups defined by estrogen receptor status in metastatic tumor.'}, {'type': 'PRIMARY', 'title': 'Clinical Response by RECIST Criteria of Estrogen Receptor Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estrogen Receptor Negative', 'description': 'Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy'}, {'id': 'OG001', 'title': 'Estrogen Receptor Positive', 'description': 'Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Increasing Disease', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Not Evaluated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months.', 'description': 'Per response evaluation criteria in Solid Tumors Criteria (RECIST 1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \\>=30% decrease in the sum of the longest diameter of target lesions. Overall Response = CR+PR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number eligible and treated participants within groups defined by estrogen receptor status'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 or Greater Toxicity by Common Toxicity Criteria Version 3.0 That Were at Least Possibly Related to Study Drug.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grade 3 (CTCAE v 3.0)', 'description': 'Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0'}, {'id': 'OG001', 'title': 'Grade 4 (CTCAE v 3.0)', 'description': 'Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0'}, {'id': 'OG002', 'title': 'Grade 5', 'description': 'Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Metabolic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neurologic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis/embolism, regardless of attribution', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study treatment and up to 30 days after stopping study', 'description': 'Adverse events at least possibly related to Fulvestrant using Common Terminology Criteria version 3.0 that were grade 3 or higher with the exception of the reported Grade 5. Grade 5 adverse events were reported regardless of attribution to study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ineligible', 'description': 'Not eligible'}, {'id': 'FG001', 'title': 'Estrogen Receptor Negative', 'description': 'Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy'}, {'id': 'FG002', 'title': 'Estrogen Receptor Positive', 'description': 'Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Still receiving treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Refused further treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Estrogen Receptor Negative', 'description': 'Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy'}, {'id': 'BG001', 'title': 'Estrogen Receptor Positive', 'description': 'Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '65.9', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Total number of eligible and treated participants by estrogen receptor status in metastatic tumor'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'lastUpdateSubmitDate': '2019-03-08', 'studyFirstSubmitDate': '2000-12-06', 'resultsFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-20', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks', 'timeFrame': 'Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.', 'description': 'Primary outcome measured according to RECIST v1.0 Best Response:\n\nComplete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart\n\nDisease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.\n\nPartial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required\n\nStable Disease is any condition not meeting the above criteria.\n\nIndeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.'}, {'measure': 'Clinical Response by RECIST Criteria of Estrogen Receptor Expression', 'timeFrame': 'Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months.', 'description': 'Per response evaluation criteria in Solid Tumors Criteria (RECIST 1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \\>=30% decrease in the sum of the longest diameter of target lesions. Overall Response = CR+PR'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Grade 3 or Greater Toxicity by Common Toxicity Criteria Version 3.0 That Were at Least Possibly Related to Study Drug.', 'timeFrame': 'During study treatment and up to 30 days after stopping study', 'description': 'Adverse events at least possibly related to Fulvestrant using Common Terminology Criteria version 3.0 that were grade 3 or higher with the exception of the reported Grade 5. Grade 5 adverse events were reported regardless of attribution to study treatment.'}]}, 'conditionsModule': {'conditions': ['Recurrent Uterine Corpus Carcinoma', 'Stage III Uterine Corpus Cancer AJCC v7', 'Stage IV Uterine Corpus Cancer AJCC v7']}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Compare the probability of clinical response in estrogen receptor (ER)-positive vs ER-negative patients with recurrent, persistent, or metastatic endometrial cancer treated with fulvestrant.\n\nII. Compare the relationship between response rate and intensity of receptor expression in patients treated with this drug.\n\nIII. Determine the frequency and intensity of toxicity of this drug in these patients.\n\nOUTLINE:\n\nPatients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria:\n\n* Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that is not curable with surgery or radiotherapy\n* Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry\n\n * ER positive or negative allowed\n* Measurable disease:\n\n * At least 1 target lesion not within a previously irradiated field OR irradiated target lesion with clear disease progression\n * At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, MRI, OR at least 10 mm by spiral CT scan\n* Performance status:\n\n * GOG 0-1\n* Hematopoietic:\n\n * Absolute neutrophil count \\>= 1,500/mm\\^3\n * Platelet count \\>= 100,000/mm\\^3\n * No prior bleeding diathesis (disseminated intravascular coagulation, clotting factor deficiency, or requirement for anticoagulants)\n* Hepatic:\n\n * Bilirubin =\\< 1.5 times upper limit of normal (ULN)\n * SGOT =\\< 3 times ULN\n * Alkaline phosphatase =\\< 3 times ULN\n* Renal:\n\n * Creatinine =\\< 2 mg/dL\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No hypersensitivity to castor oil\n* No other concurrent malignancy except nonmelanoma skin cancer\n* No other prior malignancy within past 5 years\n* No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer\n* No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that has subsequently recurred\n* At least 3 weeks since prior hormonal therapy and recovered\n* At least 3 weeks since prior radiotherapy and recovered\n* At least 3 weeks since prior surgery and recovered'}, 'identificationModule': {'nctId': 'NCT00006903', 'briefTitle': 'Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Phase II Study of Faslodex ? in Recurrent/Metastatic Endometrial Carcinoma', 'orgStudyIdInfo': {'id': 'GOG-0188'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00581', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000068339'}, {'id': 'GOG-0188', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'GOG-0188', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (fulvestrant)', 'description': 'Patients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Fulvestrant']}], 'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'otherNames': ['Faslodex', 'Faslodex(ICI 182,780)', 'ICI 182,780', 'ICI 182780', 'ZD9238'], 'description': 'Given intramuscularly', 'armGroupLabels': ['Treatment (fulvestrant)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Allan L Covens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NRG Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}