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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01434459
Recruitment Status : Terminated (PI moved to different institution)
First Posted : September 15, 2011
Last Update Posted : May 4, 2015
Information provided by (Responsible Party):
Bassel El-Rayes, Emory University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Cholangiocarcinoma Drug: Gemcitabine with TheraSphere Phase 1

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  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
Study Start Date : September 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : September 2014

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01434459

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Hyun Kevin Kim, MD Emory University Winship Cancer Institute
Principal Investigator: Bassel El-Rayes, MD Emory University Winship Cancer Institute

Responsible Party: Bassel El-Rayes, Professor, Emory University Identifier: NCT01434459     History of Changes
Other Study ID Numbers: IRB00047233a
WCI1907-10 ( Other Identifier: Other )
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: May 2015

Keywords provided by Bassel El-Rayes, Emory University:
Pancreatic neoplasms

Additional relevant MeSH terms:
Pancreatic Neoplasms
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs