Neoadjuvant Pazopanib in Renal Cell Carcinoma
|ClinicalTrials.gov Identifier: NCT01361113|
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : May 10, 2017
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Pazopanib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Primary Completion Date :||January 2015|
|Study Completion Date :||February 27, 2017|
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
- 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.
- Number of Participants Who Needed an 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|