Overview

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

Status:
Terminated

Trial end date:
2014-09-01

Target enrollment:
0

Participant gender:
All

Summary

Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer. The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Emory University

Treatments:

Gemcitabine

Criteria

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.