Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab (LCCC0921)
This is an open label Phase II Trial that using the investigational anti-cancer agent, Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by decreasing the size of the tumor or stopping its growth.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Center Open Label Phase II Study of Pazopanib in Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer After Progression on First Line Therapy Containing Bevacizumab|
- Best overall response and progression free survival [ Time Frame: Eight (8) months w additional time for response date to mature ] [ Designated as safety issue: Yes ]CR + PR + SD equal to or greater than 12 weeks that will evalute the activity of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who have progressed on first line therapy containing bevacizumab
- Estimate combined response rate CR + PF of pazopanib according to RECIST [ Time Frame: 8 months with additional time for response to mature ] [ Designated as safety issue: No ]To estimate the progression free survival (time of enrollment until disease progression or death) and overall survival from time of enrollment to death. To evaluate the safety and tolerability of pazopanib using the NCI CTCAE version 4.0 To explore potential correlations betweel blood biomarkers and clinical response
|Study Start Date:||December 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Single Intervention
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib, 800 mg by mouth daily each 21 day cycle
This multi-centered phase II trial will examine pazopanib stage IIIB/IV non-squamous NSCLC patients who have progressed on first-line therapy containing bevacizumab. Treatment should continue until disease progression, unacceptable toxicity, study withdrawal, or death. Patients who progress will be treated at the discretion of their physician. all patients who initiate treatment will be evaluated for disease control rate, which is the primary endpoint of this study.
The primary objective is to estimate the disease control rate of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who progressed while on bevacizumab. Disease control rate id defined as complete (CR) + partial response (PR) + stable disease (SD) lasting greater than or equal to 12 weeks as defined by RECIST.
Secondary Objectives To estimate the combined response rate (CR + PR) of pazopanib according to RECIST To estimate the progression free survival (defined as time of enrollment until disease progression or death) and overall survival (defined as time of enrollment until death) of patients treated with pazopanib.
To evaluate the safety and tolerability of pazopanib using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0 To explore potential correlations between blood biomarkers and clinical response.
Pazopanib is dosed continuously throughout the study. Cycle lengths are identified as 21 days for purposes of the calendar.
The treatment dosage and administration for participating subjects will be, Pazopanib, 800 mg by mouth daily during a 21 day cycle until disease progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262820
|United States, North Carolina|
|North Carolina Cancer Hospital at U of North Carolina at CH|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Thomas Stinchcombe, MD||North Carolina Cancer Hospital at University of NC at Chapel Hill|