Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Malignant Pleural Effusion
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: imatinib mesylate
Other: immunohistochemistry staining method
|Study Design:||Endpoint Classification: 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|
- Overall response rate (complete and partial responses) as assessed by RECIST criteria [ Time Frame: Baseline, Week 4 of courses 2, 4 and 6 ] [ Designated as safety issue: No ]
- Time to tumor progression [ Time Frame: Baseline and every 2 months post treatment ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 3 months for 5 years ] [ Designated as safety issue: No ]
- Toxicity rates as assessed by overall percentage of patients experiencing Grade 3 or higher toxicity and overall percentage of patients experiencing toxicity within a clinically significant category [ Time Frame: Days 3, 10, and 17 of courses 1-6 ] [ Designated as safety issue: Yes ]
- Correlation of PDGF expression in the tumor samples with the response rate and survival [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor, chemotherapy)
Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO 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.
Drug: imatinib mesylate
Other Names:Drug: paclitaxel
Other Names:Other: immunohistochemistry staining method
Optional correlative studies
Other Name: immunohistochemistry
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408460
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Renato Martins||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|