Status:
TERMINATED
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
Lead Sponsor:
Emory University
Conditions:
Pancreatic Neoplasms
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
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-s...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma
- 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
- No prior systemic therapy for advanced stage disease
- Measurable target tumors using standard imaging techniques
- Lung shunting less than 20%
- ECOG performance status 0-1 (See Appendix )
- Age ≥ 18 years
- No other investigational agents while on protocol
- Signed informed consent
Exclusion
- Inadequate hepatic function: AST/ALT \> five times upper limit of normal, Bilirubin \>2.0 mg/dl or history of hepatic encephalopathy
- Inadequate renal function Creatinine \> 2.0 mg/dL
- Inadequate bone marrow function: platelets \< 100,000/mL or absolute neutrophil count \<1500/mL
- Contraindication to angiography
- Prior external beam radiotherapy to the upper abdomen
- Clinical evidence of peritoneal metastasis or ascites
- Patients with extensive tumor replacement in the liver defined as \>50% of liver involved with tumor
- Any serious ongoing extra-hepatic disease such as infections.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01434459
Start Date
September 1 2011
End Date
September 1 2014
Last Update
May 4 2015
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322