Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma

NCT02512692 | Terminated DMC FDA Device

• 1 other identifier: 102254
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

intrahepatic cholangiocarcinoma; cholangiocarcinoma; 90Y TARE; radioembolization; gemcitabine and cisplatin

Outcome Measures

Primary Outcomes (1)

• To determine the feasibility of 90Y TARE in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.

  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

Study Arms (1)

90Y TARE with Gemcitabine and Cisplatin

EXPERIMENTAL

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); Drug: Gemcitabine; Drug: Cisplatin

Interventions

SIR-Spheres microspheres (Yttrium-90 Microspheres) DEVICE

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

Also known as: 90Y TARE

90Y TARE with Gemcitabine and Cisplatin

Gemcitabine DRUG

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

90Y TARE with Gemcitabine and Cisplatin

Cisplatin DRUG

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

90Y TARE with Gemcitabine and Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Samuel L. Cooper, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 31, 2015
• Study Start: July 21, 2015
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)