Phase II Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer
A Phase II Study of Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer
Sponsor study identifier
Secondary identifiers
OTHER · Stanford University
OTHER · OnCore
interventional
43
1 country
2
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
July 2015
Actual (reported)We will combine an oral investigational vascular endothelial growth factor (VEGF inhibitor) called pazopanib which is being studied in kidney cancer will be combined with standard chemotherapy called taxol in patients with relapsed recurrent urothelial cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 15, 2010
Actual (reported)April 21, 2010
Actual (reported)January 2015
Actual (reported)July 2015
Actual (reported)June 9, 2017
Actual (reported)Objective Tumor Response
The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories: * Complete response (CR) = Disappearance of all target lesions * Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions * Stable disease (SD) = Small changes that do not meet above criteria Objective tumor response means those with response better than stable disease, ie, complete response (CR) + partial response (PR).
Every 8 weeks
Progression-free Survival (PFS)
4 years
Cycle of 28 days. Pazopanib: 800mg daily Cycle of 28 days Paclitaxel: 80mg/m2 on days 1,8 and 15
Cycle of 28 days. Pazopanib: 800mg/day
Stanford University School of Medicine
Stanford, California, 94305, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Dr. Sandy Srinivas
Stanford University
43 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2010
First Posted
April 21, 2010
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Overall Response Rate
4 years
Overall Survival
4 years
Median Overall Survival (OS) by Bellmunt Score
4 years
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
July 2015
Actual (reported)Last Updated
June 9, 2017
Results First Posted
June 9, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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