Stage IIIB/IV Non-Small Cell Lung Cancer
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.
|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|
- 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).
|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)|
Experimental: Pazopanib plus Paclitaxel
Pazopanib daily and weekly Paclitaxel IV.
Drug: Pazopanib plus Paclitaxel
Pazopanib daily and weekly paclitaxel IV
|Contact: Janice Dunnefirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60123|
|Contact: Janice Dunne 708-327-3229 email@example.com|
|Contact: Ann Lau Clark 708-327-3221 firstname.lastname@example.org|
|Principal Investigator: Danielle Shafer, D.O.|
|Sub-Investigator: Cheryl Czerlanis, M.D.|
|Sub-Investigator: Kathy Albain, M.D.|