Stage III Pancreatic Cancer Clinical Trial
Official title:
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
This phase I trial studies the side effects and best dose of ultrasound-guided photodynamic therapy with porfimer sodium when given together with gemcitabine hydrochloride in treating patients with locally advanced pancreatic cancer. Photodynamic therapy uses a drug, porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving photodynamic therapy together with gemcitabine hydrochloride may be effect in patients with pancreatic cancer.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
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