Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin

Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered
for the trial. The patients wre being treated in groups of thre patients. Each three
patients receive a pre-specified dose of gemcitabine with full dose radioembolization using
theraspheres. If no significant side effects are observed then three additional three
patients will be treated with a higher dose of gemcitabine. The purpose to identify the
highest dose of gemcitabine that can be safely combined with theraspheres.

Inclusion Criteria:

1. Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma

2. Liver predominant disease defined as

- Cholangiocarcinoma: liver disease should be unresectable

- Limited extra hepatic metastasis defined as: i. Lung metastasis: 6 or less nodules
with no nodule greater than 1.5 cm.

ii. Abdominal lymph nodes iii. Pancreatic primary as long as the size is less than 4
cm in size iv. Bone metastasis

3. No prior systemic therapy for advanced stage disease

4. Measurable target tumors using standard imaging techniques

5. Lung shunting less than 20%

6. ECOG performance status 0-1 (See Appendix )

7. Age ≥ 18 years

8. No other investigational agents while on protocol

9. Signed informed consent

Exclusion Criteria:

1. Inadequate hepatic function: AST/ALT > five times upper limit of normal, Bilirubin
>2.0 mg/dl or history of hepatic encephalopathy

2. Inadequate renal function Creatinine > 2.0 mg/dL

3. Inadequate bone marrow function: platelets < 100,000/mL or absolute neutrophil count
<1500/mL

4. Contraindication to angiography

5. Prior external beam radiotherapy to the upper abdomen

6. Clinical evidence of peritoneal metastasis or ascites

7. Patients with extensive tumor replacement in the liver defined as >50% of liver
involved with tumor

8. Any serious ongoing extra-hepatic disease such as infections.