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.
Based on the results from the Phase 1 study of pazopanib combined with paclitaxel and the activity of paclitaxel in urothelial cancer, testing this regimen in a disease where there is an unmet need appears appropriate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Cycle of 28 days. Pazopanib: 800mg/day
Cycle of 28 days Paclitaxel: 80mg/m2 days 1,8 and 15
Stanford University School of Medicine
Stanford, California, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
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).
Time frame: Every 8 weeks
Progression-free Survival (PFS)
Time frame: 4 years
Overall Response Rate
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 Tumor response rate by each response criteria.
Time frame: 4 years
Overall Survival
Overall survival is reported as the median survival of the evaluable subjects (ie, completed 2 cycles of treatment).
Time frame: 4 years
Median Overall Survival (OS) by Bellmunt Score
Comparison between the participant's baseline Bellmunt prognostic risk factor score and survival rates. The Bellmunt prognostic risk factor score is a tool that is often used to predict treatment outcomes before initiating a secondline treatment regimen. The risk factors used to calculate the Bellmunt score include: * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 * Presence of liver metastases * Presence of visceral involvement (defined as liver, lung, bone or any non-lymph node) * Lymph node-only involvement * Hemoglobin concentration \< 10 g/dL The score is calculated based on the presence of 0; 1; 2; or 3 of the above prognostic factors. This outcome reports median overall survival based on whether the participant had 0; 1; 2; or 3 prognostic factors.
Time frame: 4 years
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