Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2014 |
Start Date: | December 2010 |
End Date: | December 2015 |
Contact: | Donna Rowe, RN |
Email: | donna_rowe@med.unc.edu |
Phone: | (919) 966-7359 |
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
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.
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.
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.
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.
Inclusion Criteria:
- Age 18 or older
- Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph
node involvement) or stage IV NSCLC
- Evidence of progression while on bevacizumab
- Patients treated for CNS metastases who are asymptomatic with no requirement for
steroids for 2 weeks prior to first dose of study drug
Exclusion Criteria:
- Prior malignancy
- Clinically significant gastrointestinal abnormalities
- Presence of uncontrolled infection or nonhealing wound, fracture, or ulcer
- History of cardiovascular conditions within the past 6 months
We found this trial at
3
sites
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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