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
I. To estimate the clinical efficacy of the combination of weekly paclitaxel and
intermittent imatinib in elderly patients with advanced non-small cell lung cancer.
I. To evaluate the safety profile of the combination of weekly paclitaxel and intermittent
imatinib in elderly patients with advanced non-small cell lung cancer.
II. To collect paraffin tissue blocks for a companion project evaluating the expression of
platelet derived growth factor (PDGF) by original tumor specimens, and its relationship to
response rate and survival.
Patients receive paclitaxel intravenously (IV) on days 3, 10, and 17 and imatinib mesylate
orally (PO) once daily (QD) on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days
for 4-6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete and partial responses) as assessed by RECIST criteria
Baseline, Week 4 of courses 2, 4 and 6
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|