Stage IIIB/IV Non-Small Cell Lung Cancer
Conditions
Non Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
non small cell lung cancer, Pazopanib, Stage IIIB/IV non small cell lung cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pazopanib plus Paclitaxel
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Location
Loyola University Medical Center
Maywood, Illinois, United States
Status: Recruiting
Contact: Janice Dunne - 708-327-3229 - jdunne@lumc.edu
Start Date
June 2011
Completion Date
September 2015
Sponsors
Loyola University
Source
Loyola University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page