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
Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Unresectable Extrahepatic Bile Duct Cancer
About this trial
This is an interventional treatment trial for Cholangiocarcinoma of the Extrahepatic Bile Duct
Eligibility Criteria
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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
- Axcan Pharma, Incorporated