Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Emory University
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
