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

Phase 1
18 Years
Open (Enrolling)
Pancreatic Neoplasms, Cholangiocarcinoma

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Trial Information

Phase I Trial 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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The maximum tolerated dose of gemcitabine when given in combination with therasphere

Outcome Description:

Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Hyun Kevin Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Pancreatic Neoplasms
  • Cholangiocarcinoma
  • Pancreatic neoplasms
  • Cholangiocarcinoma
  • Neoplasms
  • Liver Neoplasms
  • Pancreatic Neoplasms
  • Cholangiocarcinoma



Emory University Atlanta, Georgia  30322