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Clinical Trial Record

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

2011-09

2014-01

2014-09

9

Study Overview

Study 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.

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.

  • Pancreatic Neoplasms
  • Cholangiocarcinoma
  • DRUG: Gemcitabine with TheraSphere
  • IRB00047233a
  • WCI1907-10 (OTHER Identifier) (OTHER: Other)

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 Registration Dates Results Reporting Dates Study Record Updates

2011-09-12  

N/A  

2015-05-01  

2011-09-14  

N/A  

2015-05-04  

2011-09-15  

N/A  

2015-05  

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Gemcitabine with TheraSphere

DRUG: Gemcitabine with TheraSphere

  • Gemcitabine dose will be escalated and combined with therasphere.
Primary Outcome MeasuresMeasure DescriptionTime Frame
The maximum tolerated dose of gemcitabine when given in combination with theraspherePatients 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 MeasuresMeasure DescriptionTime Frame
Toxicities (side effects) experienced by patients on the trialAny 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 .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 criteria78 days
The progression free of patients treated on the trialThe 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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

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

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

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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