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.
DISEASE CHARACTERISTICS: Histologically proven malignant bile duct obstruction with
obstructive jaundice Primary carcinoma of bile duct, gallbladder, or pancreas OR
Metastatic bile duct disease Successful insertion of a percutaneous drain or endoscopic
stent Unresectable disease OR Resectable disease but refusal of surgery Prior biliary
plastic or metallic stent allowed, if requiring stent replacement due to recurrent
jaundice or routine plastic stent change No erosion of biliary tumors into major blood
vessels No evidence of bile duct perforation
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin at least 2 mg/dL
Renal: Not specified Other: No history of allergies or hypersensitivity to porphyrins No
porphyria No cholangitis or pancreatitis
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent
radiotherapy or brachytherapy to the abdomen Surgery: See Disease Characteristics Other:
No other prior or concurrent experimental or investigational drugs