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.

Condition	Treatment or Intervention	Phase
Bile Duct Cancer Gallbladder Cancer Pancreatic Cancer	Procedure: laser therapy  Procedure: phototherapy  Procedure: photodynamic therapy  Drug: porfimer sodium	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Hans Gerdes,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067110; MSKCC-99015; NCI-G99-1525
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003923
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08