Current Clinical Trials

Patients with unresectable extrahepatic bile duct cancer have cancer that cannot be completely removed by the surgeon. These patients represent the majority of cases of bile duct cancer. Often a proximal bile duct cancer invades directly into the adjacent liver or into the hepatic artery or portal vein. Portal hypertension may result. Spread to distant parts of the body is uncommon, though transperitoneal and hematogenous hepatic metastases do occur with bile duct cancers of all sites. Invasion along the biliary tree and into the liver is common.

Standard treatment options:

• These patients cannot be cured, but relief of bile duct obstruction is warranted when symptoms such as pruritus and hepatic dysfunction outweigh other symptoms from the cancer. Such palliation can be achieved by anastomosis of the bile duct to the bowel or by the placement of bile duct stents by operative, endoscopic, or percutaneous techniques.[1,2] Palliative radiation therapy after biliary bypass or intubation may be beneficial for some patients. If a percutaneous catheter has been placed, it can be used as a conduit for placement of sources for brachytherapy.[3,4] Patients with unresectable tumors should be considered for inclusion in clinical trials whenever possible.

Treatment options under clinical evaluation:

1. Patients with unresectable disease can be considered candidates for inclusion in clinical trials that explore ways to improve the effects of radiation therapy with various radiation sensitizers such as hyperthermia, radiosensitizer drugs, or cytotoxic chemotherapeutic agents.
2. Patients with unresectable disease can be considered candidates for phase I and II studies of chemotherapeutic agents or biologics. Fluorouracil, doxorubicin, and mitomycin have been reported to produce transient partial remissions in a small proportion of patients. Other drugs and drug combinations await evaluation.[5]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with unresectable extrahepatic bile duct cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Nordback IH, Pitt HA, Coleman J, et al.: Unresectable hilar cholangiocarcinoma: percutaneous versus operative palliation. Surgery 115 (5): 597-603, 1994.  [PUBMED Abstract]
   
   
2. Levy MJ, Baron TH, Gostout CJ, et al.: Palliation of malignant extrahepatic biliary obstruction with plastic versus expandable metal stents: An evidence-based approach. Clin Gastroenterol Hepatol 2 (4): 273-85, 2004.  [PUBMED Abstract]
   
   
3. Fritz P, Brambs HJ, Schraube P, et al.: Combined external beam radiotherapy and intraluminal high dose rate brachytherapy on bile duct carcinomas. Int J Radiat Oncol Biol Phys 29 (4): 855-61, 1994.  [PUBMED Abstract]
   
   
4. Shin HS, Seong J, Kim WC, et al.: Combination of external beam irradiation and high-dose-rate intraluminal brachytherapy for inoperable carcinoma of the extrahepatic bile ducts. Int J Radiat Oncol Biol Phys 57 (1): 105-12, 2003.  [PUBMED Abstract]
   
   
5. Hejna M, Pruckmayer M, Raderer M: The role of chemotherapy and radiation in the management of biliary cancer: a review of the literature. Eur J Cancer 34 (7): 977-86, 1998.  [PUBMED Abstract]
   
   

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