Know Cancer

forgot password

Phase II Study of Photodynamic Therapy With PHOTOFRIN (Porfimer Sodium) for Injection in Patients With Malignant Bile Duct Obstruction

Phase 2
18 Years
Not Enrolling
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer, Pancreatic Cancer

Thank you

Trial Information

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.

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Hans Gerdes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

February 2002

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • cholangiocarcinoma of the gallbladder
  • cholangiocarcinoma of the extrahepatic bile duct
  • adult primary cholangiocellular carcinoma
  • Cholestasis
  • Liver Neoplasms
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms



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