Phase I/II Study of Gleevec (Imatinib Mesylate, Formerly Known as STI571) and Gemcitabine for Advanced Pancreas Cancer
- Determine the maximum tolerated dose of imatinib mesylate and gemcitabine hydrochloride
in patients with locally advanced, metastatic, or recurrent pancreatic cancer.
- Determine the clinical response rate in patients treated with this regimen.
- Determine the 6-month and overall survival of patients treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
- Correlate response with expression of platelet-derived growth factor (PDGF) and PDGF
receptor in tumor tissue from patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
- Phase I: Patients receive oral imatinib mesylate once daily on days 1-14 and
gemcitabine hydrochloride IV over 30 minutes on days 1 and 8*. Treatment repeats every
21 days for up to 6 courses in the absence of disease progression or unacceptable
Cohorts of 3-5 patients receive escalating doses of imatinib mesylate and gemcitabine
hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose preceding that at which 2 of 5 or 3 of 5 patients experience dose-limiting
NOTE: *The first cohort receives gemcitabine hydrochloride on days 1, 8, and 15
- Phase II: Patients receive imatinib mesylate and gemcitabine hydrochloride at the MTD
determined in phase I in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine maximum tolerated dose according to toxicity
After 1 cycle of therapy (1 cycle = 21 days)
Mary Mulcahy, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|