Neoadjuvant Pazopanib in Renal Cell Carcinoma
This study will be a single arm phase II clinical trial of 8 weeks of daily, oral neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically confirmed localized renal cell carcinoma (RCC).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Pazopanib: A Phase II Study to Evaluate the Effect on Disease Response and Recurrence and to Establish Predictive Biomarkers of Drug Activity in Renal Cell Carcinoma|
- Response rate [ Time Frame: 8 weeks after neoadjuvant treatment ] [ Designated as safety issue: No ]Determine the objective response rate (CR+PR) using RECIST 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma
- Recurrence Free Survival (RFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Estimate recurrence free survival (RFS) following neoadjuvant treatment with pazopanib followed by nephrectomy, specifically reporting the 1 year and 2 year rate estimates with their 95% confidence intervals.
- Altered surgical approach after treatment with pazopanib [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]Determine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response.
- Number of participants with adverse events [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]Identify any safety issues in subjects treated with pazopanib, neoadjuvantly, followed by nephrectomy.
- Predictive molecular markers in response to treatment with pazopanib [ Time Frame: 1 year ] [ Designated as safety issue: No ]To assess the correlation between the expression of biomarkers and CT scan response. Patients are considered as responders when objective response (partial or complete response) is shown on CT scan and measured by RECIST version 1.1
- Exploratory Analysis of Objective Response and Recurrence Free Survival rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]To preform and exploratory analysis of the objective response rate (OR) and recurrence free survival (RFS) rates in the evaluable group who receives 4-7 weeks of therapy separately from the evaluable group who receives 8 weeks of therapy.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Single arm trial
800 mg orally once daily for 8 weeks, prior to nephrectomy
Other Name: Votrient
The primary objective of this study is to determine the objective response rate Complete Response + Partial Response(CR+PR) associated with neoadjuvant pazopanib at 8 weeks as defined via RECIST1.1. The investigators will also estimate the recurrence free survival (RFS), specifically the 1 and 2 year rates, with recurrence defined via RECIST1.1, and characterize the safety issues. Finally, this study also includes a number of exploratory analyses designed to evaluate potential correlations between RFS and; serum levels of cytokine and angiogenesis factor (CAF).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361113
|Contact: Gayle Grigson, RN||(919) firstname.lastname@example.org|
|Contact: Dale Flowers, RN||(919) email@example.com|
|United States, New York|
|Weill Cornell Medical College||Withdrawn|
|New York, New York, United States, 10065|
|United States, North Carolina|
|North Carolina Cancer Hospital (UNC)||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Carolinas HealthCare System||Withdrawn|
|Charlotte, North Carolina, United States, 28262|
|Duke University Medical Center||Withdrawn|
|Durham, North Carolina, United States, 27710|
|United States, South Carolina|
|Medical University of South Carolina (MUSC)||Withdrawn|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Christopher Wood, MD|
|Principal Investigator:||Kimryn Rathmell, MD||UNC Lineberger Comprehensive Cancer Center|