Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer (6137p)
This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer|
- To estimate the clinical efficacy of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To evaluate the safety profile of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Drug: Gleevec, paclitaxel
- Imatinib mesylate
Each 28-day cycle includes three weekly doses of intravenous paclitaxel, administered on Day 3,10, and 17.
Each 28-day cycle includes 12 daily doses of oral Gleevec (imatinib mesylate). Imatinib is administered in four-day pulses. Pulses bracket each paclitaxel infusion as follows: Days 1-4, Days 8-11, Days15-18. Each imatinib dose is 600 mg.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011075
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|University of New Mexico Cancer Center @ Lovelace Medical Center|
|Albuquerque, New Mexico, United States, 87102|
|Principal Investigator:||Julie Bauman, MD||University of New Mexico Cancer Center|