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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

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ClinicalTrials.gov Identifier: NCT00268450
Recruitment Status : Terminated
First Posted : December 22, 2005
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Biological: bevacizumab
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Procedure: cysectomy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Study Intervention

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.

bevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles

After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles

cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles

gemcitabine 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

paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles

cysectomy


Participant Flow:   Overall Study
    Study Intervention
STARTED   21 
COMPLETED   21 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Study Intervention

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.

bevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles

After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles

cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles

gemcitabine 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

paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles

cysectomy


Baseline Measures
   Study Intervention 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  61.9% 
>=65 years      8  38.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  19.0% 
Male      17  81.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   9.5% 
White      19  90.5% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   21 


  Outcome Measures

1.  Primary:   Complete Remission Rate   [ Time Frame: From day of first treatment until after cycle 3 ]

2.  Secondary:   Urinary Survivin Levels   [ Time Frame: Baseline, week 6 and week 12 ]

3.  Secondary:   Urinary Cytogenitics   [ Time Frame: baseline and week 12 ]

4.  Secondary:   Progression Free Survival   [ Time Frame: from first treatment until time of progression or death, whichever comes first ]

5.  Secondary:   Median Overall Surivial   [ Time Frame: from first treatment until death ]

6.  Secondary:   Percentage of Planned Dose Received   [ Time Frame: from first treatment until end of week 12 ]

7.  Secondary:   Rate of Post-operative Complications   [ Time Frame: from first treatment until up to 48 hours after surgery. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kate Anderton
Organization: Medical University of South Carolina
phone: 843-792-2708
e-mail: anderton@musc.edu



Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00268450     History of Changes
Other Study ID Numbers: CDR0000454937
MUSC-AVF-3312
MUSC-HR-15537
GENENTECH-AVF-3312
MUSC-CTO-100892
First Submitted: December 20, 2005
First Posted: December 22, 2005
Results First Submitted: May 4, 2018
Results First Posted: July 12, 2018
Last Update Posted: July 12, 2018