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

April 2, 2013 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Mont-Saint-Hilaire, Quebec, Canada, J3H 6C4
        • Axcan Pharma, Incorporated
  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Performance status

  • Karnofsky 30-100%

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

  • Not specified

Other

  • 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

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • More than 13 weeks since prior and no concurrent chemotherapy

Radiotherapy

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

Surgery

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

Other

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: James Farrell, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 11, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

December 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXCAN-PHOCCC04-01
  • UCLA-0501033-01
  • CDR0000449701 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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