Neoadjuvant Pazopanib in Renal Cell Carcinoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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 ]
Determine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma.
Evaluation of Target Lesions using RECIST 1.1 Criteria:
Complete response (CR)−Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to <10mm.
Partial response (PR)−At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD.
- Recurrence Free Survival (RFS) [ Time Frame: 2 years ]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 ]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 Related to Treatment. [ Time Frame: 9 weeks ]
Identify any safety issues in subjects treated with pazopanib, neoadjuvantly, followed by nephrectomy. Number of patients that had adverse events reported that had an attribution of; possible, probable, or definite that are graded a 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event.
- Predictive Molecular Markers in Response to Treatment With Pazopanib [ Time Frame: 1 year ]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 ]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:||June 2011|
|Study Completion Date:||January 2017|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Single Arm Neoadjuvant Pazopanib
Pazopanib 800 mg PO once daily for 8 weeks
800 mg orally once daily for 8 weeks, prior to nephrectomy
Other Name: Votrient
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361113
|United States, North Carolina|
|North Carolina Cancer Hospital (UNC)|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||William Kim, MD||UNC Lineberger Comprehensive Cancer Center|