Neoadjuvant Pazopanib in Renal Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01361113|
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : May 10, 2017
Last Update Posted : April 25, 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|
|Actual Primary Completion Date :||January 7, 2015|
|Actual Study Completion Date :||February 15, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|