Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-03-05 @ 4:55 PM
Study NCT ID:
NCT00548418
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
2007-10-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mutchd@wudosis.wustl.edu', 'phone': '314-362-2181', 'title': 'David G. Mutch, M.D.', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the start of treatment through 30 days following the end of treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Cisplatin, Topotecan, Bevacizumab)', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle', 'otherNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constitutional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Genitourinary/renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Esophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Elevated creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Blood clot/DVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bladder spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bone fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sudden cardiovascular collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anti-tumor Activity as Measured by Surviving Progression-free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cisplatin, Topotecan, Bevacizumab)', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Progression-free survival at 6 months', 'description': 'Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cisplatin, Topotecan, Bevacizumab)', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'comment': 'An 80% confidence interval was calculated and ranged from 8 to 15.4.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until death (follow-up ranged from 1.7 months to 33.4 months)', 'description': 'Defined as time from study entry until death from any cause or date of last contaqct.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Response as Measured by RECIST Criteria (Imaging)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cisplatin, Topotecan, Bevacizumab)', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)', 'description': 'RECIST criteria:\n\nComplete response 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\nPartial Response 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.\n\nProgression is defined as ANY of the following - 20% increase in the sum of LD target lesions, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease, progression of existing non-target lesions\n\nStable disease is any condition not meeting the above criteria', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '26 participants were evaluable for response.'}, {'type': 'SECONDARY', 'title': 'Correlate Patterns of Gene Expression as Assessed by Microarrays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cisplatin, Topotecan, Bevacizumab)', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle'}], 'timeFrame': 'Correlative studies when specimens available', 'reportingStatus': 'POSTED', 'populationDescription': 'None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.'}, {'type': 'SECONDARY', 'title': 'Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cisplatin, Topotecan, Bevacizumab)', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle'}], 'timeFrame': 'When specimens available', 'reportingStatus': 'POSTED', 'populationDescription': 'None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Cisplatin, Topotecan, Bevacizumab)', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment to the study opened to participants on 02/20/07 and enrollment to the study was closed to participants on 11/07/11.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Cisplatin, Topotecan, Bevacizumab)', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Performance status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'GOG/Zubrod Description\n\n0 = Fully active, able to carry on all pre-disease performance without restriction\n\n1. = Restricted in physically strenuous activitiy but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work\n2. = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours\n3. = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours\n4. = Completely disabled', 'unitOfMeasure': 'participants'}, {'title': 'Disease stage', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': "Stage I: The cancer has grown into the cervix, but it is not growing outside the uterus. The cancer has not spread to nearby lymph nodes or distant sites.\n\nStage II: The cancer has grown beyond the cervix and uterus, but hasn't spread to the walls of the pelvis or the lower part of the vagina.\n\nStage III: The cancer has spread to the lower part of the vagina or the walls of the pelvis. The cancer may be blocking the ureters. It has not spread to nearby lymph nodes or distant sites.\n\nStage IV:The cancer has spread to nearby organs or other parts of the body.", 'unitOfMeasure': 'participants'}, {'title': 'Histologic type', 'classes': [{'title': 'Squamous cell', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Adenocarcinoma', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Grade', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '1. well differentiated\n2. moderately differentiated\n3. poorly differentiated', 'unitOfMeasure': 'participants'}, {'title': 'Prior hysterectomy', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-28', 'studyFirstSubmitDate': '2007-10-23', 'resultsFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2007-10-23', 'lastUpdatePostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-27', 'studyFirstPostDateStruct': {'date': '2007-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-tumor Activity as Measured by Surviving Progression-free', 'timeFrame': 'Progression-free survival at 6 months', 'description': 'Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Until death (follow-up ranged from 1.7 months to 33.4 months)', 'description': 'Defined as time from study entry until death from any cause or date of last contaqct.'}, {'measure': 'Frequency of Response as Measured by RECIST Criteria (Imaging)', 'timeFrame': 'Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)', 'description': 'RECIST criteria:\n\nComplete response 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\nPartial Response 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.\n\nProgression is defined as ANY of the following - 20% increase in the sum of LD target lesions, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease, progression of existing non-target lesions\n\nStable disease is any condition not meeting the above criteria'}, {'measure': 'Correlate Patterns of Gene Expression as Assessed by Microarrays', 'timeFrame': 'Correlative studies when specimens available'}, {'measure': 'Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies', 'timeFrame': 'When specimens available'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '23591400', 'type': 'DERIVED', 'citation': 'Zighelboim I, Wright JD, Gao F, Case AS, Massad LS, Mutch DG, Powell MA, Thaker PH, Eisenhauer EL, Cohn DE, Valea FA, Alvarez Secord A, Lippmann LT, Dehdashti F, Rader JS. Multicenter phase II trial of topotecan, cisplatin and bevacizumab for recurrent or persistent cervical cancer. Gynecol Oncol. 2013 Jul;130(1):64-8. doi: 10.1016/j.ygyno.2013.04.009. Epub 2013 Apr 13.'}], 'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the combination of topotecan, cisplatin and bevacizumab is effective in the treatment of recurrent or persistent cervical cancer', 'detailedDescription': 'Cervical cancer remains a major cause of morbidity and mortality in women. Chemoradiation has led to improvements in survival, but the prognosis for patients with recurrent, metastatic cervical cancer remains poor. There is the need for more effective treatments for the management of recurrent/persistent cervical cancer. Angiogenesis appears to play an important role in cervical cancer development and progression, therefore VEGF inhibition appears to be a rationale therapeutic strategy for cervical cancer. There is increasing evidence that combining an anti-angiogenic agent with either cytotoxic chemotherapy or radiation enhances anti-tumor activity. This study combines the current most active chemotheraputic regimen for cervical cancer (cisplatin + topotecan) with an anti-angiogenic agent.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent or persistent squamous, adenosquamous or adenocarcinoma of the uterine cervix not amenable to curative treatment with surgery and/or radiotherapy\n* No prior therapy (radiation, chemotherapy, hormonal therapy or immunotherapy) for recurrence or persistence. May have received platinum in combination with radiation as part of up-front treatment or adjuvant treatment\n* Must have measurable disease as defined by RECIST criteria\n* Must have at least one "target lesion" to assess response\n* Performance status of 0 or 1\n* Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry\n* At least 4 weeks must have elapsed since prior treatment\n* Age \\>= 18 years\n* Patients of childbearing potential must have a negative pregnancy test, use effective means of contraception\n* Signed informed consent\n* Bone marrow function: ANC \\>= 1500/ul; platelets \\>= 100,000 /ul\n* Renal function: creatinine \\<= 1,5 X ULN (if \\> 1.5 creatinine clearance must be \\> 60 ml/min)\n* Hepatic function: bilirubin \\<= 1.5 X ULN, AST and alkaline phosphatase \\<= 2.5 X ULN\n* Neurologic function: neuropathy \\< CTC grade 1\n* Coagulation: PT INR \\<= 1.5\n\nExclusion Criteria:\n\n* Evidence of sepsis or severe infection\n* Prior therapy for recurrence\n* Patients with serious, non-healing wound, ulcer or bone fracture\n* Patients with history or evidence of nervous system disease, including primary brain tumor, brain metastases, seizure not controlled with standard medical therapy, CVA, stroke, TIA or subarachnoid hemorrhage within 6 months of 1st date of treatment on study\n* Patients with history of other invasive malignancy (treatment within last 5 years) other than non-melanoma skin cancer\n* Patient with clinically significant cardiovascular disease defined as:\n* Inadequately controlled hypertension (systolic \\> 150 and/or diastolic \\> 100 on antihypertensive medications); prior history of hypertensive crisis or hypertensive encephalopathy\n* Unstable angina within 6 months of enrollment\n* NYHA Grade II or greater congestive heart failure\n* Serious cardiac arrythmia requiring medication\n* Grade 2 or greater peripheral vascular disease; claudication within 6 months\n* History of myocardial infarction within 6 months\n* Previously diagnosed coagulopathy, disseminated intravascular coagulopathy, immune thrombocytopenia purpura, thrombotic thrombocytopenia purpura or tumor involving major vessels\n* Significant vascular disease: aortic aneurysm, aortic dissection\n* Active thromboembolic disease: pulmonary embolism, deep venous thrombosis\n* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study; anticipation of need for major surgical procedure during course of the study\n* Minor surgical procedure other than central venous access placement, within 7 days prior to day 1 of study\n* Patients with proteinuria - patients with urine protein of 1+ on dipstick or \\>=30 mg/dl at baseline should undergo UPCR; patients with UPCR of \\>=1.0 should be excluded\n* Patients who are pregnant or lactating\n* No prior investigational agent within 30 days or planned participation in an experimental drug study\n* Patients whose circumstances do not permit completion of study or required follow-up\n* Prior therapy with bevacizumab or topotecan. Prior platinum therapy allowed as part of initial treatment\n* History of abdominal fistula, GI perforation or intra-abdominal abscess within 6 months prior to study enrollment.\n* Known hypersensitivity to any component of bevacizumab'}, 'identificationModule': {'nctId': 'NCT00548418', 'briefTitle': 'Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Phase II Trial of Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer', 'orgStudyIdInfo': {'id': '06-1098 / 201110266'}, 'secondaryIdInfos': [{'id': 'GSK 107278'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle\n\nTopotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle\n\nBevacizumab 15 mg/kg day 1 of a 21 day cycle', 'interventionNames': ['Drug: Topotecan', 'Drug: Cisplatin', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Topotecan', 'type': 'DRUG', 'otherNames': ['Hycamtin'], 'armGroupLabels': ['I']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['CDDP', 'Platin'], 'armGroupLabels': ['I']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'armGroupLabels': ['I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University College of Medicine', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'David G Mutch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}