Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab (LCCC0921)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01262820
First received: December 7, 2010
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: Pazopanib
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 36
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pazopanib
    Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
    Other Name: Pazopanib
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262820

Contacts
Contact: Donna Rowe, RN (919) 966-7359 donna_rowe@med.unc.edu
Contact: Diane Winans (919) 843-2742 diane_winans@med.unc.edu

Locations
United States, North Carolina
North Carolina Cancer Hospital at U of North Carolina at CH Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Maureen Tynan, RN    919-966-4432    tynanm@med.unc.edu   
Contact: Honey Strickland, RN OCN    919-966-4432    honey_strickland@med.unc.edu   
Principal Investigator: Thomas E Stinchcombe, MD         
Sub-Investigator: Mark Socinski, MD         
Sub-Investigator: Juneko Grilley Olson, MD         
Rex Cancer Center at Rex Hospital Withdrawn
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
GlaxoSmithKline
Investigators
Principal Investigator: Thomas Stinchcombe, MD North Carolina Cancer Hospital at University of NC at Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01262820     History of Changes
Obsolete Identifiers: NCT01107652
Other Study ID Numbers: LCCC0921
Study First Received: December 7, 2010
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Pazopanib
Non Squamous Non Small Cell Lung Cancer
After Progress on first line therapy
Using Bevacizumab

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014