Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery (Photostent-02)

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histopathological/cytological diagnosis of nonresectable locally advanced, recurrent, or metastatic biliary tract carcinoma (intra- or extra-hepatic), or gallbladder carcinoma
• Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible)

Exclusion criteria:

• Porphyria
• No brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0, 1, 2, or 3
• Estimated life expectancy > 3 months
• Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 1 month after completion of treatment
• Not pregnant or nursing

Exclusion criteria:

• History of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, or any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously)
• Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
• Any psychiatric or other disorder likely to impact on informed consent

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• Patients may have undergone a non-curative operation (i.e., R2 resection [with macroscopic residual disease] or palliative bypass surgery only) and fully recovered

  • Patients who have previously undergone curative surgery must have evidence of non-resectable disease relapse

• Patients may have received prior radiotherapy within the past 28 days (with or without radio-sensitizing low-dose chemotherapy) for localized disease and fully recovered

  • Must have clear evidence of disease progression prior to inclusion in this study

• Patients may have received prior chemotherapy within the past 28 days and fully recovered

  • Must have clear evidence of disease progression prior to inclusion in this study

Exclusion criteria:

• Previous treatment with curative intent for current disease in the last 12 weeks (i.e., prior resection, radical radiotherapy, or chemotherapy)
• Previous treatment with experimental therapy for current disease in the last 12 weeks
• No cytotoxic chemotherapy, radiotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications will be permitted for the first four weeks of the study