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

Primary Purpose

Pancreatic Neoplasms, Cholangiocarcinoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine with TheraSphere

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreatic neoplasms, Cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Emory University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine with TheraSphere

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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.

Full Information

NCT ID

NCT01434459

First Posted

September 12, 2011

Last Updated

May 1, 2015

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT01434459

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Why Stopped

PI moved to different institution

Study Start Date

September 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms, Cholangiocarcinoma

Keywords

Pancreatic neoplasms, Cholangiocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine with TheraSphere

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Gemcitabine with TheraSphere

Other Intervention Name(s)

TheraSphere_radioembolization, Gemcitabine- Gemzar

Intervention Description

Gemcitabine dose will be escalated and combined with therasphere.

Primary Outcome Measure Information:

Title

The maximum tolerated dose of gemcitabine when given in combination with therasphere

Description

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Toxicities (side effects) experienced by patients on the trial

Description

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.

Time Frame

90 days

Title

Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .

Description

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

Time Frame

78 days

Title

The progression free of patients treated on the trial

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyun Kevin Kim, MD

Organizational Affiliation

Emory University Winship Cancer Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bassel El-Rayes, MD

Organizational Affiliation

Emory University Winship Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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