Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma

November 15, 2024 updated by: Medical University of South Carolina

A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Gemcitabine and cisplatin chemotherapy is the current standard for the treatment of unresectable intrahepatic cholangiocarcinoma. 90Y TARE combined with the current standard may be an ideal way to improve disease control in the liver as almost all patients die from their disease in the liver. The data from this trial would then be used to move to a phase II trial to determine efficacy to see if a phase III trial would be warranted. In addition, assessment of the molecular classification of intrahepatic cholangiocarcinoma could determine if there is difference in survival with chemotherapy and 90Y TARE. Finally, MRI before and after treatment will be used to determine if utilizing the percent increase of mean ADC correlates with survival.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

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
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

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

Description

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.

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the feasibility of 90Y TARE in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.
Time Frame: Up to 2 years
A continual reassessment method (CRM) design will be used to confirm the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in regards to 90Y TARE.
Up to 2 years

Collaborators and Investigators

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

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Samuel L. Cooper, MD, Medical University of South Carolina

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 (Actual)

July 21, 2015

Primary Completion (Actual)

March 19, 2021

Study Completion (Actual)

March 19, 2021

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimated)

July 31, 2015

Study Record Updates

Last Update Posted (Actual)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102254 (GSK)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

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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