Open-label, Single-center, Non-randomized, Phase I, Dose-ranging Study of Endoscopic Ultrasound (EUS) Guided Photodynamic Therapy (PDT) With Photofrin® in Locally Advanced Pancreatic Cancer
I. To determine the safety of increasing porfimer sodium (PHO) dose and total energy by
endoscopic ultrasound (EUS)-guided photodynamic therapy (PDT) for locally advanced
unresectable pancreatic cancer (PC) in humans.
I. Quantify computed tomography (CT) detected volume of tumor necrosis produced by EUS-PDT.
II. Quantify rates of tumor size stabilization or decrease by EUS PDT and determine
objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
III. Determine surgical downstaging off of abdominal vessels and resectability. IV.
Determine changes in serum cancer antigen (CA) 19-9 levels with treatment. V. Evaluate
progression-free and overall survival.
OUTLINE: This is a dose-escalation study of EUS-PDT with porfimer sodium.
Patients receive porfimer sodium intravenously (IV) on day 1 and undergo EUS-PDT on days 1,
3, 8, and 21. After completion of EUS-PDT, patients receive gemcitabine hydrochloride IV
over 30 minutes on days 1, 8, and 15 of courses 1 and 2 and on day 22 of courses 3 and 5.
During courses 1-5, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity. After course 5, treatment with gemcitabine hydrochloride repeats
every 2 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the number of subjects with adverse events which occur when up to 3 sites within the pancreas are treated with PDT using a total dose of 50 or 100 J per site
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).
Up to 4 years
John M DeWitt, MD
United States: Institutional Review Board
|IU Simon Cancer Center||Indianapolis, Indiana 46202|