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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dihematoporphyrin Ether; Trioxsalen

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