Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab

Lung Cancer Clinical Trial

— LCCC0921  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262820
• Other study ID #: LCCC 0921
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2010
• Last updated: July 1, 2016
• Start date: December 2010
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01107652

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Pazopanib
Pazopanib, 800 mg by mouth daily each 21 day cycle

Locations

Country	Name	City	State
United States	North Carolina Cancer Hospital at U of North Carolina at CH	Chapel Hill	North Carolina
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best overall response and progression free survival	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	Eight (8) months w additional time for response date to mature	Yes
Secondary	Estimate combined response rate CR + PF of pazopanib according to RECIST	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	8 months with additional time for response to mature	No

External Links

•   web address for Lineberger Comprehensive Cancer Center at UNC
•   web address for the National Cancer Institute (NCI)