Gemcitabine and Pazopanib in Chemotherapy Naïve Patients With Advanced/Metastatic Urothelial Carcinoma Ineligible for Cisplatin-based Chemotherapy

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: NCT01622660
Recruitment Status : Terminated (Safety reasons)
First Posted : June 19, 2012
Results First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Drug: Gemcitabine
Drug: Pazopanib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual 06/14/2012 Protocol Closed to Accrual 02/05/2014 Primary Completion Date 02/03/2016 Recruitment Location is the medical clinic

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
Gemcitabine and Pazopanib Chemotherapy naïve participants with advanced/metastatic urothelial carcinoma ineligible for Cisplatin-based chemotherapy

Participant Flow:   Overall Study
    Gemcitabine and Pazopanib
Adverse Event                1 

  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
Gemcitabine and Pazopanib

This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.

Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles.

Baseline Measures
   Gemcitabine and Pazopanib 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      1  50.0% 
>=65 years      1  50.0% 
[Units: Years]
Mean (Full Range)
 (60 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      0   0.0% 
Male      2 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      2 100.0% 
Unknown or Not Reported      0   0.0% 
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      0   0.0% 
White      2 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
United States   2 

  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 2 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Dean Bajorin
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-422-4333

Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT01622660     History of Changes
Other Study ID Numbers: 11-191
First Submitted: June 15, 2012
First Posted: June 19, 2012
Results First Submitted: January 23, 2017
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017