A Phase 1 Study of Gemcitabine, Dasatinib and Erlotinib in Patients With Advanced Pancreatic Carcinoma
I. To determine the maximum tolerated dose (also phase II recommended dose) of the
combination of gemcitabine (gemcitabine hydrochloride), erlotinib (erlotinib hydrochloride)
and dasatinib in patients with advanced pancreatic adenocarcinoma.
I. To determine the safety profile of the combination of gemcitabine, erlotinib and
II. To evaluate the response rate and response duration of advanced pancreatic
adenocarcinoma treated with dasatinib, erlotinib and gemcitabine.
III. To determine progression- free survival and overall survival for this group of
IV. To determine the utility of advanced magnetic resonance imaging techniques to assess in
vivo effects of therapy (changes in tumor vascularity, cellularity).
V. To assess the use of serum markers as predictors of response and outcome.
OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride and dasatinib.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8,
and 15, and dasatinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days
1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up for 30 days and then every 4
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of gemcitabine hydrochloride and dasatinib given together with erlotinib hydrochloride, determined by incidence of dose-limiting toxicity (DLT) graded according to NCI CTCAE v 4.0
Up to 4 weeks after completion of study treatment
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|