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

May 1, 2015 updated by: Bassel El-Rayes, Emory University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemcitabine with TheraSphere
Drug: Gemcitabine with TheraSphere
Gemcitabine dose will be escalated and combined with therasphere.
Other Names:
  • TheraSphere_radioembolization
  • Gemcitabine- Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum tolerated dose of gemcitabine when given in combination with therasphere
Time Frame: 28 days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicities (side effects) experienced by patients on the trial
Time Frame: 90 days
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
Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .
Time Frame: 78 days
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
The progression free of patients treated on the trial
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Hyun Kevin Kim, MD, Emory University Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (Estimate)

September 15, 2011

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00047233a
  • WCI1907-10 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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