Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-27 @ 5:05 AM
Study NCT ID:
NCT00268450
Status:
TERMINATED
Last Update Posted:
2018-07-12
First Post:
2005-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'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'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anderton@musc.edu', 'phone': '843-792-2708', 'title': 'Kate Anderton', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Data not collected for this outcome measure', 'eventGroups': [{'id': 'EG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Remission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'timeFrame': 'From day of first treatment until after cycle 3', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected'}, {'type': 'SECONDARY', 'title': 'Urinary Survivin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'timeFrame': 'Baseline, week 6 and week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected'}, {'type': 'SECONDARY', 'title': 'Urinary Cytogenitics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'timeFrame': 'baseline and week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'timeFrame': 'from first treatment until time of progression or death, whichever comes first', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected'}, {'type': 'SECONDARY', 'title': 'Median Overall Surivial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'timeFrame': 'from first treatment until death', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected'}, {'type': 'SECONDARY', 'title': 'Percentage of Planned Dose Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'timeFrame': 'from first treatment until end of week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected'}, {'type': 'SECONDARY', 'title': 'Rate of Post-operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'timeFrame': 'from first treatment until up to 48 hours after surgery.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.\n\nbevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles\n\ncisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles\n\ngemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles\n\npaclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles\n\ncysectomy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', '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': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', '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': '21', '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': 21}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2005-12-20', 'resultsFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-13', 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Remission Rate', 'timeFrame': 'From day of first treatment until after cycle 3'}], 'secondaryOutcomes': [{'measure': 'Urinary Survivin Levels', 'timeFrame': 'Baseline, week 6 and week 12'}, {'measure': 'Urinary Cytogenitics', 'timeFrame': 'baseline and week 12'}, {'measure': 'Progression Free Survival', 'timeFrame': 'from first treatment until time of progression or death, whichever comes first'}, {'measure': 'Median Overall Surivial', 'timeFrame': 'from first treatment until death'}, {'measure': 'Percentage of Planned Dose Received', 'timeFrame': 'from first treatment until end of week 12'}, {'measure': 'Rate of Post-operative Complications', 'timeFrame': 'from first treatment until up to 48 hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transitional cell carcinoma of the bladder', 'stage III bladder cancer', 'stage II bladder cancer', 'recurrent bladder cancer'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.\n\nPURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with locally advanced nonmetastatic bladder cancer that can be removed by surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed transitional cell cancer (TCC) of the bladder\n\n * Staged as follows:\n\n * Muscle invasive (T2-T4a)\n * Node negative (N0)\n\n * No histologically or cytologically proven lymph node metastases\n * Nonmetastatic (M0)\n\n * No evidence of distant metastases\n* Resectable disease\n* Able to begin protocol treatment within 6 weeks after transurethral resection and cystoscopic evaluation\n* No central nervous system or brain metastases\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status of 0-2\n* Karnofsky 60-100%\n* White blood cell count ≥ 3,000/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* AST(SGOT) and ALT(SGPT) ≤ 2 times upper limit of normal\n* Bilirubin ≤1.5 mg/dL\n* Creatinine clearance ≥ 60 mL/min\n* Urine protein/creatinine ratio \\< 1.0\n* Blood pressure ≤150/100 mm Hg\n* No prohibitive medical risks for chemotherapy\n* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, gemcitabine hydrochloride, or paclitaxel\n* No unstable angina\n* No history of myocardial infarction within the past 6 months\n* No cardiac arrhythmias\n* No New York Heart Association (NYHA) congestive heart failure ≥ grade 2\n* No history of stroke within the past 6 months\n* No clinically significant peripheral vascular disease\n* No evidence of bleeding diathesis or coagulopathy\n* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months\n* No serious nonhealing wound, ulcer, or bone fracture\n* No psychiatric illness or other psychosocial situation that would limit ability to comply with study and/or follow-up procedures\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must agree to use adequate contraception prior to study entry and for the duration of study participation\n* No significant traumatic injury with in the past 28 days\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior systemic chemotherapy\n* No prior pelvic radiation therapy\n* More than 4 weeks since prior participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study\n* No concurrent participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study\n* No major surgical procedure or open biopsy within the past 28 days\n* No anticipation of need for major surgical procedure during the course of the study\n* No minor surgical procedures, fine-needle aspirations, or core biopsies within the past 7 days\n* No concurrent treatment with hormones or other chemotherapeutic agents except the following:\n\n * Steroids given for adrenal failure\n * Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)\n * Intermittent use of dexamethasone as an antiemetic in solid tumor protocols\n* No other concurrent investigational or commercial agents or therapies'}, 'identificationModule': {'nctId': 'NCT00268450', 'briefTitle': 'Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder', 'orgStudyIdInfo': {'id': 'CDR0000454937'}, 'secondaryIdInfos': [{'id': 'MUSC-AVF-3312'}, {'id': 'MUSC-HR-15537'}, {'id': 'GENENTECH-AVF-3312'}, {'id': 'MUSC-CTO-100892'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study intervention', 'description': 'Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.', 'interventionNames': ['Biological: bevacizumab', 'Drug: cisplatin', 'Drug: gemcitabine hydrochloride', 'Drug: paclitaxel', 'Procedure: cysectomy']}], 'interventions': [{'name': 'bevacizumab', 'type': 'BIOLOGICAL', 'otherNames': ['avastin'], 'description': 'Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles\n\nAfter surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles', 'armGroupLabels': ['study intervention']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': 'Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles', 'armGroupLabels': ['study intervention']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'description': 'Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles', 'armGroupLabels': ['study intervention']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': 'After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles', 'armGroupLabels': ['study intervention']}, {'name': 'cysectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['study intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Hollings Cancer Center at Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29501', 'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'facility': 'McLeod Regional Medical Center', 'geoPoint': {'lat': 34.19543, 'lon': -79.76256}}, {'zip': '29464-3233', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Lowcountry Hematology and Oncology, PA', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gibbs Regional Cancer Center at Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}], 'overallOfficials': [{'name': 'Andrew S. Kraft, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Gustavo Leone', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of South Carolina, Hollings Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}