Stent Placement With or Without Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Treating Patients With Stage III or Stage IV Cholangiocarcinoma That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00253617
Recruitment Status : Withdrawn
First Posted : November 15, 2005
Last Update Posted : April 4, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Stent placement may help reduce symptoms caused by the tumor. Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for cholangiocarcinoma. It is not yet known whether stent placement and photodynamic therapy using porfimer sodium are more effective than stent placement alone in treating cholangiocarcinoma.

PURPOSE: This randomized phase III trial is studying stent placement and photodynamic therapy using porfimer sodium to see how well they work compared to stent placement alone as palliative treatment in treating patients with stage III or stage IV cholangiocarcinoma that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma of the Gallbladder Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Drug: porfimer sodium Procedure: adjuvant therapy Procedure: laser therapy Procedure: photodynamic therapy Procedure: phototherapy Phase 3

Detailed Description:



  • Compare the overall survival time in patients with unresectable Bismuth type III or IV, stage III-IV cholangiocarcinoma treated with double plastic endoprostheses insertion with vs without adjuvant photodynamic therapy using porfimer sodium as palliative treatment.


  • Compare the effect of these regimens on cholestasis in these patients.
  • Compare the 1-year survival rate in patients treated with these regimens.
  • Compare health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to participating center.

Patients undergo endoscopic or percutaneous drainage followed by insertion of bilateral plastic endoprostheses into the bile ducts. Patients are then randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive porfimer sodium IV on day 1. Patients undergo endoscopic laser light therapy to the tumor site on day 3.
  • Arm II: Patients receive no further treatment. Quality of life is assessed at baseline and then at weeks 2, 13, 26, 39, 52, and 65.

After completion of study treatment, patients are followed within 30-90 days.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Double Plastic Endoprosthesis Insertion With Versus Without Adjuvant Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Patients With Unresectable Stage III-IV Cholangiocarcinoma

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed cholangiocarcinoma
  • Stage III or IV disease
  • Bismuth type III or IV disease
  • Tumor mass or stricture on cholangiogram and CT scan
  • Unresectable disease


Performance status

  • Karnofsky 30-100%

Life expectancy

  • Not specified


  • WBC ≥ 2,000/mm^3
  • Platelet count ≥ 50,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hematocrit ≥ 27%


  • PT or INR ≤ 2 times upper limit of normal (correctable with vitamin K)
  • No decompensated cirrhosis


  • Not specified


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known porphyria or hypersensitivity to porphyrin
  • No clinically significant acute or chronic medial or psychological illness that would preclude study treatment
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
  • No concurrent untreated primary diagnosis of anxiety or depression



  • More than 13 weeks since prior and no concurrent chemotherapy


  • More than 13 weeks since prior and no concurrent brachytherapy or radiotherapy


  • No prior metal stent insertion
  • No prior surgical resection of cholangiocarcinoma


  • No prior photodynamic therapy for this disease
  • More than 60 days since prior investigational drugs
  • No concurrent administration of the following:
  • Ursodiol
  • Herbal products that may increase bile flow, including any of the following:
  • Andrographis paniculata
  • Chelidonium majus L
  • Curcumin L
  • Cynara scolymus L (artichoke)
  • Gentiana lutea
  • Mentha x piperita (peppermint)
  • Peumus boldus Mol
  • Taraxacum officinale (dandelion)
  • No administration of any of the following within 7 days of porfimer sodium injection:
  • Supplements in vitamins C, E, and β-carotene
  • Camellia sinensis (green tea)
  • Silymarin
  • EGb761

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00253617

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Canada, Quebec
Axcan Pharma, Incorporated
Mont-Saint-Hilaire, Quebec, Canada, J3H 6C4
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: James Farrell, MD Jonsson Comprehensive Cancer Center Identifier: NCT00253617     History of Changes
Other Study ID Numbers: AXCAN-PHOCCC04-01
CDR0000449701 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: December 2006

Additional relevant MeSH terms:
Gallbladder Neoplasms
Bile Duct Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Dihematoporphyrin Ether
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents