Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer
- Evaluate the time to progression in patients with locally advanced or metastatic
pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as
- Assess the response rate in patients treated with this regimen.
- Assess the percentage of patients treated with this regimen who survive 1 year or more.
- Assess the toxicity of this regimen in these patients.
- Assess the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, nonrandomized, open-label, uncontrolled study.
Patients receive gemcitabine hydrochloride IV over 120 minutes on days 3 and 10 and oral
imatinib mesylate on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival in months.
Elizabeth A. Poplin, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|New Jersey Medical School||Newark, New Jersey 07103-2714|
|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|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Jersey Shore Cancer Center at Jersey Shore University Medical Center||Neptune, New Jersey 07754-0397|
|CentraState Medical Center||Freehold, New Jersey 07728|
|Central Jersey Oncology Group||New Brunswick, New Jersey 08901|