Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-small Cell Lung Cancer (NSCLC)
OBJECTIVES:
Primary
- Evaluate the response rate in patients with recurrent or metastatic non-small cell lung
cancer treated with gemcitabine hydrochloride and imatinib mesylate.
Secondary
- Assess time to progression in patients treated with this regimen.
- Assess overall survival and 1-year survival of patients treated with this regimen.
- Assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, nonrandomized, uncontrolled, open-label study.
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate
once daily on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response and partial response)
No
Mika Sovak, MD, PhD
Principal Investigator
Cancer Institute of New Jersey
United States: Federal Government
CDR0000539557
NCT00323362
April 2006
October 2008
Name | Location |
---|---|
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |