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

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ClinicalTrials.gov Identifier: NCT02512692
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE July 29, 2015
First Posted Date  ICMJE July 31, 2015
Last Update Posted Date September 6, 2018
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2015)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2015)
Presence or absence of a 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)
Change History Complete list of historical versions of study NCT02512692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Official Title  ICMJE A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intrahepatic Cholangiocarcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Device: SIR-Spheres microspheres (Yttrium-90 Microspheres)
  • Drug: Gemcitabine
  • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2016)
24
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2015)
20
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02512692
Other Study ID Numbers  ICMJE 102254
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel L. Cooper, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP