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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01434459
• Other study ID #: IRB00047233a
• Secondary ID: WCI1907-10
• Status: Terminated
• Phase: Phase 1
• First received: September 12, 2011
• Last updated: May 1, 2015
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Liver Neoplasms
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine with TheraSphere
Gemcitabine dose will be escalated and combined with therasphere.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum tolerated dose of gemcitabine when given in combination with therasphere	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.	28 days	Yes
Secondary	Toxicities (side effects) experienced by patients on the trial	Any side effect experienced on the trial will be graded according to the grading system developed by the national cancer institute. The number of patients with each side effect will be calculated.	90 days	No
Secondary	Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .	Patients will receive a PET CT prior to treatment and then another PET CT scan at completion day 78. Comparison of tumor size and uptake of FDG will be performed using standard RECIST criteria	78 days	No
Secondary	The progression free of patients treated on the trial	The investigators will follow patients with serial cross sectional (CT or MRI) scans. If the tumor shows growth on the scan then the investigators will calculate the time it took for the tumor to grow.	12 months	No