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

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00253617

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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

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 Design

Study Type:

Interventional

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
2	Axcan Pharma, Incorporated	Mont-Saint-Hilaire	Quebec	Canada	J3H 6C4