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Cholangiocarcinoma of the Extrahepatic Bile DuctPhase 3NCT00253617

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

A Phase 3 study testing porfimer sodium, adjuvant therapy and laser therapy in people with Cholangiocarcinoma of the Extrahepatic Bile Duct and Cholangiocarcinoma of the Gallbladder, run by Jonsson Comprehensive Cancer Center at 2 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
porfimer sodium, adjuvant therapy and laser therapy
Type of treatment
Surgery or procedure
How many people
0 participants
Where
2 sitesin 2 countries
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

Canada1 site

  • Axcan Pharma, Incorporated

    Mont-Saint-Hilaire, Quebec, J3H 6C4

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
porfimer sodium, adjuvant therapy, laser therapy, photodynamic therapy, phototherapy
Medical subject headings
Bile Duct Neoplasms, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • porfimer sodiumDrug

  • adjuvant therapyProcedure or surgery

  • laser therapyProcedure or surgery

  • photodynamic therapyProcedure or surgery

  • phototherapyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2005 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00253617
Sponsor's protocol ID
AXCAN-PHOCCC04-01
Other IDs
UCLA-0501033-01, CDR0000449701
Status last verified
Dec 2006
First submitted
11 Nov 2005
Last updated
4 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing porfimer sodium, adjuvant therapy and laser therapy in people with Cholangiocarcinoma of the Extrahepatic Bile Duct and Cholangiocarcinoma of the Gallbladder, run by Jonsson Comprehensive Cancer Center at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00253617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.

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