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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Given IV
Undergo EUS-PDT
Undergo EUS-PDT
Given IV
IU Simon Cancer Center
Indianapolis, Indiana, United States
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).
Time frame: Up to 4 years
CT- or MRI-detected volume of tumor necrosis
Will be compared using paired t-tests or Wilcoxon rank sum tests as appropriate and changes will be plotted by maximal total energy of treatment to explore for dose-response effects.
Time frame: Week 2
Rates of tumor size stabilization or decease by EUS-PDT
Will be compared using paired t-tests or Wilcoxon rank sum tests as appropriate and changes will be plotted by maximal total energy of treatment to explore for dose-response effects.
Time frame: Up to 4 years
Objective response rate per RECIST
Time frame: Up to 4 years
Surgical downstaging off of abdominal vessels or change in tumor unresectability
Time frame: Up to 4 years
Change in CA 19-9 levels
Will be compared using paired t-tests or Wilcoxon rank sum tests as appropriate and changes will be plotted by maximal total energy of treatment to explore for dose-response effects.
Time frame: Baseline to up to 4 years
Progression-free survival
A Kaplan-Meier plot will be produced.
Time frame: From the date of initial treatment to the earliest date of disease progression, resection of measurable tumor or death for patients who fail; and to the date of disease evaluation for patients who remain at risk for failure, assessed up to 4 years
Overall survival
A Kaplan-Meier plot will be produced.
Time frame: From the day of first treatment to the earlier of death (from any cause) and the last date of patient contact, assessed up to 4 years
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