Ultrasound-Guided Photodynamic Therapy With Photofrin & Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Condition: Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Stage III Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms; Carcinoma, Acinar Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): porfimer sodium; endoscopic ultrasonography; photodynamic therapy; gemcitabine hydrochloride
Intervention type(s): Drug; Procedure; Procedure; Drug
Intervention description(s): Given IV; Undergo EUS-PDT; Undergo EUS-PDT; Given IV
Other intervention name(s): Photofrin; Photofrin II; Porfimer; endoscopic ultrasound; EUS; Light Infusion Therapy; PDT; therapy, photodynamic; gemcitabine; Gemzar; LY-188011
Intervention MeSH terms: Gemcitabine; Dihematoporphyrin Ether; Hematoporphyrin Derivative; Trioxsalen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment