Back to results90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SIR-Spheres microspheres (Yttrium-90 Microspheres)
Gemcitabine
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring intrahepatic cholangiocarcinoma, cholangiocarcinoma, 90Y TARE, radioembolization, gemcitabine and cisplatin
Eligibility Criteria
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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
90Y TARE with Gemcitabine and Cisplatin
Arm Description
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.
Outcomes
Primary Outcome Measures
Presence or absence of a dose limiting toxicity (DLT) of 90Y TARE in combination with gemcitabine and cisplatin.
A continual reassessment method (CRM) design will be used to identify the maximum-tolerated dose (MTD)
Secondary Outcome Measures
Full Information
NCT ID
NCT02512692
First Posted
July 29, 2015
Last Updated
November 11, 2021
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02512692
Brief Title
90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Official Title
A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2015 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
Keywords
intrahepatic cholangiocarcinoma, cholangiocarcinoma, 90Y TARE, radioembolization, gemcitabine and cisplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
90Y TARE with Gemcitabine and Cisplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SIR-Spheres microspheres (Yttrium-90 Microspheres)
Other Intervention Name(s)
90Y TARE
Intervention Description
On Day 3 or 4 of cycle 1 90Y TARE will be administered
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
On days 1 and 8 of each cycle (21 days) Gemcitabine will be administered. Treatment may last up to 8 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
On days 1 and 8 of each cycle (21 days) Cisplatin will be administered. Treatment may last up to 8 cycles
Primary Outcome Measure Information:
Title
Presence or absence of a dose limiting toxicity (DLT) of 90Y TARE in combination with gemcitabine and cisplatin.
Description
A continual reassessment method (CRM) design will be used to identify the maximum-tolerated dose (MTD)
Time Frame
6 weeks of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel L. Cooper, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
We'll reach out to this number within 24 hrs