Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma

NCT ID: NCT02512692

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-21
• Study Completion Date: 2021-03-19

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).

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.

Conditions

Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SIR-Spheres microspheres (Yttrium-90 Microspheres)

Intervention Type: DEVICE

On Day 3 or 4 of cycle 1 90Y TARE will be administered

Gemcitabine

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Interventions

SIR-Spheres microspheres (Yttrium-90 Microspheres)

On Day 3 or 4 of cycle 1 90Y TARE will be administered

Intervention Type: DEVICE

Gemcitabine

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Other Intervention Names

90Y TARE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel L. Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

102254

Identifier Type: -

Identifier Source: org_study_id