Brief Title
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
Official Title
Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
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 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.
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-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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
The maximum tolerated dose of gemcitabine when given in combination with therasphere
Secondary Outcome
Toxicities (side effects) experienced by patients on the trial
Condition
Pancreatic Neoplasms
Intervention
Gemcitabine with TheraSphere
Study Arms / Comparison Groups
Gemcitabine with TheraSphere
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
September 2011
Completion Date
September 2014
Primary Completion Date
January 2014
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Hyun Kevin Kim, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01434459
Organization ID
IRB00047233a
Secondary IDs
WCI1907-10
Responsible Party
Principal Investigator
Study Sponsor
Emory University
Study Sponsor
Hyun Kevin Kim, MD, Principal Investigator, Emory University Winship Cancer Institute
Verification Date
May 2015