Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer
Phase II Trial of Trifluridine/Tipiracil in Combination With Irinotecan in Biliary Tract Cancers
2 other identifiers
interventional
28
1 country
1
Brief Summary
This phase II trial studies how well trifluridine/tipiracil and irinotecan work in treating patients with biliary tract cancer that has spread to other places in the body (advanced) and has not responded to treatment (refractory). Trifluridine/tipiracil and irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2021
CompletedResults Posted
Study results publicly available
September 22, 2022
CompletedAugust 9, 2023
July 1, 2023
1.8 years
August 27, 2019
August 3, 2022
August 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Will be defined as the proportion of evaluable patients who are progression-free (stable disease, partial response, complete response) at 16 weeks and assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson.
Up to 16 weeks
Secondary Outcomes (5)
Overall Response Rate (ORR)
Up to 20 months
Disease Control Rate (DCR)
Up to 20 months
PFS
From study entry to the first of either disease progression or death from any cause, assessed up to 20 months
Overall Survival (OS)
From study entry to death from any cause, assessed up to 20 months
Number of Participants With Adverse Events
Up to 28 days
Other Outcomes (4)
Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (cfDNA) at Baseline
Baseline
Change in CTCs or cfDNA
Baseline up to 20 months
Correlation of Response
Up to 20 months
- +1 more other outcomes
Study Arms (1)
Treatment (trifluridine and tipiracil, irinotecan)
EXPERIMENTALPatients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and irinotecan hydrochloride IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given PO
Eligibility Criteria
You may qualify if:
- Histological confirmation of advanced biliary tract cancers including cancers originating in the gallbladder who have received at least one line of systemic anticancer therapy
- Note: Patients who have either progressed on or are intolerant to the prior therapy can be included in this study
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease. Disease that is measurable by physical examination only is not eligible
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Absolute neutrophil count (ANC) \>= 1500/mm\^3 (=\< 21 days prior to registration)
- Platelet count \>= 100,000/mm\^3 (=\< 21 days prior to registration)
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) (=\< 21 days prior to registration)
- Aspartate transaminase (AST) or alanine transaminase (ALT) =\< 3 x ULN (=\< 21 days prior to registration)
- Creatinine =\< 1.5 x ULN (=\< 21 days prior to registration)
- Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willingness to provide mandatory blood and tissue specimens for correlative research
You may not qualify if:
- Any of the following because this study involves an agent that has potential genotoxic, mutagenic and teratogenic effects:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ adequate contraception for at least 3 months after the last dose of the study drug
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =\< 21 days prior to registration
- Receiving any anticancer therapy for biliary tract cancer =\< 21 days prior to registration
- Other active malignancy requiring treatment in =\< 6 months prior to registration
- EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
- NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
- History of myocardial infarction =\< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Previous treatment with irinotecan or irinotecan-based chemotherapy for biliary tract cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Comprehensive Cancer Networkcollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Tella SH, Foster N, Qian S, Nguyen T, Borad MJ, McWilliams RR, Alberts SR, Wee Ma W, Chakrabarti S, Fruth B, Wessling J, Hartgers M, Washburn L, Fernandez-Zapico ME, Hogenson TL, Pitot H, Jin Z, Mahipal A. Phase II Trial of Trifluridine/Tipiracil Plus Irinotecan in Patients with Advanced, Refractory Biliary Tract Carcinoma. Oncologist. 2023 Oct 3;28(10):917-e966. doi: 10.1093/oncolo/oyad144.
PMID: 37339254DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Amit Mahipal
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Mahipal
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2019
First Posted
August 28, 2019
Study Start
October 18, 2019
Primary Completion
August 13, 2021
Study Completion
August 13, 2021
Last Updated
August 9, 2023
Results First Posted
September 22, 2022
Record last verified: 2023-07