Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-01 @ 2:25 PM
Study NCT ID:
NCT00418093
Status:
TERMINATED
Last Update Posted:
2014-06-19
First Post:
2007-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'nhorowitz@partners.org', 'phone': '617-732-8843', 'title': 'Neil Horowitz, MD', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial was closed after enrolling 19 of the 53 projected patient accrual.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergic Reaction to Oxaliplatin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Partial Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Group', 'description': 'Oxaliplatin, Gemcitabine, Bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.684', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.87', 'pValueComment': 'Exact 95% CI for the partial response rate (13/19 = 0.684): 43.4% \\~ 87.4%', 'estimateComment': 'Point estimate of PR and its exact 95% CI based on Binomial Model', 'statisticalMethod': 'Estimation of PR based on Binomial Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'We did not perform a test. Point estimate of PR and its exact 95% CI based on Binomial Model is provided. Thus there is no p-value to report.', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Single Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.684', 'ciLowerLimit': '0.434', 'ciUpperLimit': '0.874', 'pValueComment': 'We did not perform hypothesis test. We made an estimation for a single proportion (partial response) with its two-sided 95% exact Binomial confidence interval.', 'estimateComment': 'Estimation of a single proportion (partial response rate) with exact 95% Binomial confidence interval', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)', 'description': 'Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria', 'unitOfMeasure': 'percentage of patients on study', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Group', 'description': 'Oxaliplatin, Gemcitabine, Bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '48'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months', 'description': 'Time participant remains free of progression of her disease. Evaluated by RECIST criteria', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '19'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Group', 'description': 'Oxaliplatin, Gemcitabine, Bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '112.3', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '136'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months', 'description': 'Duration of time participants are alive after enrolling on the study. Assessed by clinical records', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients enrolled'}, {'type': 'SECONDARY', 'title': 'Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Group', 'description': 'Oxaliplatin, Gemcitabine, Bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Toxicities were assessed every cycle and for up to 30 days after being removed from the trial', 'description': 'The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chemotherapy Group', 'description': 'Oxaliplatin plus Gemcitabine plus Bevacizumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Completed Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'THe study was terminated early due to a lack of accural', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-18', 'studyFirstSubmitDate': '2007-01-02', 'resultsFirstSubmitDate': '2012-04-27', 'studyFirstSubmitQcDate': '2007-01-02', 'lastUpdatePostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-18', 'studyFirstPostDateStruct': {'date': '2007-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial Response Rate', 'timeFrame': 'Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)', 'description': 'Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months', 'description': 'Time participant remains free of progression of her disease. Evaluated by RECIST criteria'}, {'measure': 'Overall Survival', 'timeFrame': 'Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months', 'description': 'Duration of time participants are alive after enrolling on the study. Assessed by clinical records'}, {'measure': 'Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.', 'timeFrame': 'Toxicities were assessed every cycle and for up to 30 days after being removed from the trial', 'description': 'The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported'}]}, 'conditionsModule': {'keywords': ['mullerian carcinoma'], 'conditions': ['Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Cancer']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with recurrent mullerian carcinoma. We will also collect more information about the safety and side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors.', 'detailedDescription': "* The study treatment is divided into periods called cycles. Each cycle is 28 days long. Participants will be given the study drugs intravenously on day 1 and day 15 of each cycle.\n* Gemcitabine will be given first, over a period of 30 minutes. Then oxaliplatin over a period of 2 hours. Finally, bevacizumab will be given over a period of 30 to 90 minutes. Participants will continue study treatment as long as their tumor is not growing and they are not experiencing unacceptable side effects. If the tumor goes away completely, the participant will have 2 more cycle of study treatment.\n* Blood will be drawn for routine testing every week during study treatment to check for side effects. Before day 1 and 15 of each cycle the following tests and procedures will be performed: a medical history; complete physical exam; vital signs; blood tests; and urine tests. Before day 1 of every other cycle, the following additional procedures will be performed: A CT scan, x-ray or ultrasound of your abdomen and pelvis; an x-ray of the chest (if required by the study doctor); blood tests; and urine samples.\n* If the participant's tumor goes away, they will be asked to return to the clinic for follow-up visits every 3 months for 2 years, then every 6 months for 3 years. At each follow-up visit the following tests and procedures will be performed: medical history; complete physical examination; CT scan, x-ray or ultrasound of the abdomen and pelvis; x-ray of the chest; and other tests if the doctor feels they are needed.\n* There is an optional sub-study that six subjects will be asked to take a part in that will give the study doctors important information about the way the body uses and breaks down the study drugs. This sub-study will involve special surgical procedures and scans that will be done during cycle 1 of the study treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic or cytologic confirmation of the original primary tumor is required.\n* Must have measurable disease which is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be \\>20mm when measured by conventional techniques.\n* Must have at least one "target lesion" to be used to assess response.\n* Platinum-sensitive tumors, defined as a platinum free interval of at least 6 months, and may have had up to two prior treatment regimens.\n* Eastern Cooperative Oncology Group score of 0 or 1\n* Life expectancy of 12 weeks or longer\n* 18 years of age or older\n* Adequate bone marrow, renal, neurologic and liver function\n* Normal blood coagulation parameters\n\nExclusion Criteria:\n\n* Chemotherapy within last 3 weeks\n* Current, recent (within 4 weeks), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.\n* Known bleeding disorder or coagulopathy, or history of stroke.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry or the anticipation of need for major surgical procedure during the course of the study.\n* Minor surgical procedures within 14 days of study entry.\n* Significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, a history of deep vein thrombosis, or Grade II or greater, clinically significant peripheral vascular disease within 1 year of study entry.\n* Urine protein:creatinine ration greater than or equal to 1.0\n* History or clinical evidence of central nervous system disease\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who have evidence of disease within last three years.\n* More than 2 prior lines of chemotherapy\n* Previous treatment with a VEGF targeted inhibitor or antibody\n* Serious non-healing wound, ulcer or bone fracture\n* Prior radiation therapy to more than one-third of hematopoietic sites.\n* History of abdominal fistulas, gastrointestinal perforation, intra-abdominal abscess, or partial bowel obstruction within 6 months\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT00418093', 'briefTitle': 'Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma', 'orgStudyIdInfo': {'id': '04-356'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy', 'description': 'All patients received oxaliplatin, gemcitabine, and bevacizumab', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Oxaliplatin', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.', 'armGroupLabels': ['Chemotherapy']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.', 'armGroupLabels': ['Chemotherapy']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Given intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.', 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Neil Horowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Sanofi-Synthelabo', 'class': 'INDUSTRY'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecologic Oncologist', 'investigatorFullName': 'Neil S. Horowitz, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}