This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT01108055
First received: April 15, 2010
Last updated: May 8, 2017
Last verified: May 2017
Results First Received: January 18, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   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
  Hide 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
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
STARTED   43 
Eligible and Started Treatment   32 
COMPLETED   28 
NOT COMPLETED   15 
Ineligible                11 
Not evaluable- didn't complete treatment                4 



  Baseline Characteristics
  Hide 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
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]
 32 
Age 
[Units: Years]
Mean (Full Range)
 67 
 (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)
 4 
 (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
 
 7 
 14 
 11 
 0 


  Outcome Measures
  Show All 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
  Hide 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
  Hide 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
e-mail: sandysri@stanford.edu



Responsible Party: Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier: NCT01108055     History of Changes
Other Study ID Numbers: IRB-17472
SU-04152010-5683 ( Other Identifier: Stanford University )
BLDR0010 ( Other Identifier: OnCore )
Study First Received: April 15, 2010
Results First Received: January 18, 2017
Last Updated: May 8, 2017