Phase II Study of Photodynamic Therapy With PHOTOFRIN (Porfimer Sodium) for Injection in Patients With Malignant Bile Duct Obstruction
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
Hans Gerdes, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|