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90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02512692
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : January 14, 2020
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma (ICC).

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Device: SIR-Spheres microspheres (Yttrium-90 Microspheres) Drug: Gemcitabine Drug: Cisplatin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
Study Start Date : July 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: 90Y TARE with Gemcitabine and Cisplatin

90Y TARE will be given on day 3 or 4 of cycle 1 and start at 75% of the dose calculated by the body surface area formula and escalated by 25% per cohort in combination with cisplatin 25 mg/m2 and gemcitabine 300 mg/m2 in cycles 1 and 2.

Once the 90Y TARE has reached the 100% dose level, the gemcitabine dose will increase to 600mg/m2 in dose level 3 and 1000mg/m2 in dose level 4. The cisplatin dose will remain at 25/mg/m2.

For all dose levels, from cycle 3 to cycle 8, the cisplatin dose will be 25mg/m2 and the gemcitabine dose will be 1000mg/m2.

Device: SIR-Spheres microspheres (Yttrium-90 Microspheres)
On Day 3 or 4 of cycle 1 90Y TARE will be administered
Other Name: 90Y TARE

Drug: Gemcitabine
On days 1 and 8 of each cycle (21 days) Gemcitabine will be administered. Treatment may last up to 8 cycles

Drug: Cisplatin
On days 1 and 8 of each cycle (21 days) Cisplatin will be administered. Treatment may last up to 8 cycles

Primary Outcome Measures :
  1. Presence or absence of a dose limiting toxicity (DLT) of 90Y TARE in combination with gemcitabine and cisplatin. [ Time Frame: 6 weeks of study treatment ]
    A continual reassessment method (CRM) design will be used to identify the maximum-tolerated dose (MTD)

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologic Documentation: Core needle biopsy or surgical specimen that confirms intrahepatic cholangiocarcinoma (ICC). Patients must be determined to be unresectable by a multidisciplinary team that includes a hepatobiliary surgeon.
  • No prior liver radiation therapy or immunotherapy for cholangiocarcinoma.
  • Only one previous single agent chemotherapy for ICC allowed.
  • Patient may have prior liver resection.
  • Age > 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2 (see Appendix E)
  • Child's Pugh score of A (see Appendix F)
  • Life expectancy of greater than 4 months
  • Normal organ and marrow function as outlined in the protocol.
  • Willingness to use effective contraceptive methods during the study. Patient may participate in the female (or female partner of male subject), either is not of childbearing potential (defined as postmenopausal for > 1 year or surgically sterile) or is practicing two forms of contraception. Sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide).
  • Patients with well controlled HIV infection are eligible if their CD4 count is >499/cu mm and viral load is < 50 copies/ml.
  • Pre-certification for the 90Y TARE should be performed prior to enrollment on this study.
  • All patients must be informed of the investigational nature of this study and must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had major surgery within 4 weeks prior to entering the study or those who have not recovered from complications from a surgery more than 4 weeks earlier.
  • Patients may not be receiving any other investigational agents.
  • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association (NYHA) Criteria
  • Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as defined by Child-Pugh Class B or C
  • Pregnant women are excluded from this study.

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): NCT02512692

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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Sarah Annand    843-792-9321   
Sponsors and Collaborators
Medical University of South Carolina
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Principal Investigator: Samuel L. Cooper, MD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina Identifier: NCT02512692    
Other Study ID Numbers: 102254
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Medical University of South Carolina:
intrahepatic cholangiocarcinoma
gemcitabine and cisplatin
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs