Pancreatic Cancer Clinical Trial
Official title:
Phase II Study of Photodynamic Therapy With PHOTOFRIN (Porfimer Sodium) for Injection in Patients With Malignant Bile Duct Obstruction
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive
to light to kill tumor cells. This may be effective treatment for cancer of the bile duct,
gallbladder, or pancreas.
PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating
patients who have cancer of the bile duct, gallbladder, or pancreas.
OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer
sodium in patients with unresectable malignant bile duct obstruction.
OUTLINE: Patients are stratified according to tumor location (proximal vs distal). Patients
receive porfimer sodium IV over 3-5 minutes on day 1, followed by percutaneous or endoscopic
laser light treatment on day 3. Patients achieving partial response or complete response
accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a
maximum of 3 courses. Patients are followed weekly for 1 month, and then monthly for 1 year.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
;
Primary Purpose: Treatment
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