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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Drug: porfimer sodium
* Procedure: adjuvant therapy
* Procedure: laser therapy
* Procedure: photodynamic therapy
* Procedure: phototherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: porfimer sodium|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: laser therapy|nan|
|Procedure: photodynamic therapy|nan|
|Procedure: phototherapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |