Clinical trial NCT01434459: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pancreatic Neoplasms
Cholangiocarcinoma
Keywords: Pancreatic neoplasms
Cholangiocarcinoma
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The maximum tolerated dose of gemcitabine when given in combination with therasphere
timeFrame: 28 days
Secondary outcomes:
measure: Toxicities (side effects) experienced by patients on the trial
timeFrame: 90 days
measure: Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .
timeFrame: 78 days
measure: The progression free of patients treated on the trial
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Hyun Kevin Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University Winship Cancer Institute
name: Bassel El-Rayes, MD
role: PRINCIPAL_INVESTIGATOR
References: