A Phase II Study of Intermittent GleevecĀ® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-Small Cell Lung Cancer
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
Interventional
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
No
Renato Martins
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
6137
NCT00408460
February 2006
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |