Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer
OBJECTIVES:
Primary
- Evaluate the time to progression in patients with locally advanced or metastatic
pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as
first-line therapy.
Secondary
- 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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival
Progression-free survival in months.
4 years
No
Elizabeth A. Poplin, MD
Principal Investigator
Cancer Institute of New Jersey
United States: Institutional Review Board
CDR0000539409
NCT00161213
September 2005
October 2010
Name | Location |
---|---|
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 |