Clinical trial NCT01262820: Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Pazopanib
Non Squamous Non Small Cell Lung Cancer
After Progress on first line therapy
Using Bevacizumab
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-12-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease Control Rate
timeFrame: Eight (8) months w additional time for response date to mature (up to 2 years per participant)
Secondary outcomes:
measure: Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1
timeFrame: 8 months with additional time for response to mature (up to 2 years per participant)
measure: Progression Free Survival
timeFrame: Eight (8) months w additional time for response data to mature (up to 2 years per participant)
measure: Overall Survival
timeFrame: Eight (8) months w additional time for response date to mature (up to 2 years per participant)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Cancer Hospital at U of North Carolina at CH
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: North Carolina Cancer Hospital at University of NC at Chapel Hill
name: Thomas Stinchcombe, MD
role: PRINCIPAL_INVESTIGATOR
References: