Status:
WITHDRAWN
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
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cholangiocarcinoma of the Extrahepatic Bile Duct
Cholangiocarcinoma of the Gallbladder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. W...
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 wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00253617
Last Update
April 4 2013
Active Locations (2)
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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