Phase II Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108055
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bladder Cancer
Bladder (Urothelial, Transitional Cell) Cancer
Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy)
Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable
Interventions: Drug: Pazopanib (GW786034)
Drug: Paclitaxel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Pazopanib + Paclitaxel A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.

Participant Flow:   Overall Study
    Pazopanib + Paclitaxel
Eligible and Started Treatment   32 
Ineligible                11 
Not evaluable- didn't complete treatment                4 

  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.
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Reporting Groups
Pazopanib + Paclitaxel A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.

Baseline Measures
   Pazopanib + Paclitaxel 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (29 to 89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      9  28.1% 
Male      23  71.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      1   3.1% 
Not Hispanic or Latino      30  93.8% 
Unknown or Not Reported      1   3.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      4  12.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3   9.4% 
White      23  71.9% 
More than one race      0   0.0% 
Unknown or Not Reported      2   6.3% 
Prior Treatment Cycles [1] 
[Units: Cycles]
Median (Full Range)
 (1 to 14) 
[1] A full treatment cycle is defined as 28 days.
Sites of Primary Tumor 
[Units: Participants]
Count of Participants
Bladder      15  46.9% 
Renal Pelvis      11  34.4% 
Ureter      6  18.8% 
Number of prior chemotherapies 
[Units: Participants]
Count of Participants
    13  40.6% 
    19  59.4% 
Time from last chemotherapy 
[Units: Participants]
Count of Participants
< 3 months   15 
> 3 months   17 
Bellmunt Score 
[Units: Participants]
Count of Participants

  Outcome Measures

1.  Primary:   Objective Tumor Response   [ Time Frame: Every 8 weeks ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 4 years ]

3.  Secondary:   Overall Response Rate   [ Time Frame: 4 years ]

4.  Secondary:   Overall Survival   [ Time Frame: 4 years ]

5.  Secondary:   Median Overall Survival (OS) by Bellmunt Score   [ Time Frame: 4 years ]

  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
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Sandy Srinivas, MD
Organization: Stanford University
phone: 650 498 6000

Responsible Party: Sandy Srinivas, Stanford University Identifier: NCT01108055     History of Changes
Other Study ID Numbers: IRB-17472
SU-04152010-5683 ( Other Identifier: Stanford University )
BLDR0010 ( Other Identifier: OnCore )
First Submitted: April 15, 2010
First Posted: April 21, 2010
Results First Submitted: January 18, 2017
Results First Posted: June 9, 2017
Last Update Posted: June 9, 2017