Stage IIIB/IV Non-Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Loyola University
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01179269
First received: August 6, 2010
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to evaluate the response rate of pazopanib in combination with paclitaxel for untreated NSCLC patients who are not eligible for front-line therapy with a platinum doublet. This is not a minority population as the average age at diagnosis for NSCLC approximates 70. The elderly have been largely under-represented in many of the phase III NSCLC chemotherapy trials. Furthermore, the treatment of patients with performance status 2 remains controversial as they may be less likely to benefit and more likely to experience toxicity from a platinum doublet. This population has been excluded from many of the phase III combination chemotherapy protocols. The taxanes (paclitaxel and docetaxel) have demonstrated efficacy and tolerability in the treatment of advanced NSCLC. There is limited data combining an anti-angiogenesis agent with chemotherapy in the elderly and PS 2 population. By inhibiting VEGFR, PDGFR, and c-kit, pazopanib may stop or slow the rate of tumor growth and development. The combination of the two agents with minimal overlapping toxicity may afford additive anti-tumor effects.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Pazopanib plus Paclitaxel
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: Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • objective response rate of pazopanib in combination with paclitaxel [ Time Frame: an average of 2 years ] [ Designated as safety issue: No ]
    To evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the RECIST criteria (version 1.1).


Estimated Enrollment: 53
Study Start Date: June 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib plus Paclitaxel
Pazopanib daily and weekly Paclitaxel IV.
Drug: Pazopanib plus Paclitaxel
Pazopanib daily and weekly paclitaxel IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC.
  • ECOG performance status of 0-2
  • No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are permitted. Palliative radiation therapy must have ended 14 days prior to first dose of pazopanib. Subject with recurrence after previous NSCLC that has been treated with surgery with or without adjuvant chemotherapy/radiation for curative intent are eligible, provided 12 months have passed since this treatment ended.

Exclusion Criteria:

  • Appropriate for doublet therapy as first line therapy. At discretion of investigator.
  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: NCT01179269

Contacts
Contact: Janice Dunne 708-327-3229 jdunne@lumc.edu

Locations
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60123
Contact: Janice Dunne    708-327-3229    jdunne@lumc.edu   
Contact: Ann Lau Clark    708-327-3221    alausch@lumc.edu   
Principal Investigator: Danielle Shafer, D.O.         
Sub-Investigator: Cheryl Czerlanis, M.D.         
Sub-Investigator: Kathy Albain, M.D.         
Sponsors and Collaborators
Loyola University
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01179269     History of Changes
Other Study ID Numbers: 202499
Study First Received: August 6, 2010
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Loyola University:
non small cell lung cancer
Pazopanib
Stage IIIB/IV non small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014