Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

Phase 2

Completed

• Conditions: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer; Pancreatic Cancer

• Registration Number: NCT00003923
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-03
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-02
• Study Completion: 2002-02
• Study First Submitted QC: 2004-02-06
• Study First Posted: 2004-02-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States