TAS-102 in Treating Advanced Biliary Tract Cancers

NCT03278106 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1642NCI-2017-01603P30CA015083
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread to other places in the body. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Conditions

Cholangiocarcinoma; Stage III Gallbladder Cancer AJCC v7; Stage IIIA Gallbladder Cancer AJCC v7; Stage IIIB Gallbladder Cancer AJCC v7; Stage IV Gallbladder Cancer AJCC v7; Stage IVA Gallbladder Cancer AJCC v7; Stage IVB Gallbladder Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• 16-Week Progression-free Survival (PFS) Rate

  16-Week Progression-free survival (PFS) rate is defined as the percentage of patients who are progression-free (stable disease, partial response, or complete response as defined by RECIST v1.1 criteria) at 16 weeks post registration.

  16 weeks

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  Up to 3 years

• Progression-free Survival (PFS)

  Time from study entry to the first of either disease progression or death from any cause, assessed up to 3 years

• Overall Survival (OS)

  Time from study entry to death from any cause, assessed up to 3 years

• Overall Toxicity Rates (Percentages) for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)

  Up to 3 years

Other Outcomes (3)

• Change in Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA)

  Baseline up to 3 years

• Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA) Analysis at Baseline

  Baseline

• Mutation Status of the Tumor

  Up to 3 years

Study Arms (1)

Treatment (TAS-102)

EXPERIMENTAL

Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally PO BID on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Drug: Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (TAS-102)

Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 DRUG

Given PO

Also known as: Lonsurf, TAS-102, Trifluridine/Tipiracil

Treatment (TAS-102)

Eligibility Criteria

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

You may qualify if:

• Histological confirmation of advanced biliary tract cancers including cancers originating in gallbladder who have received at least one line of systemic anticancer therapy;
• Note: Patients who have either progressed or intolerant to the prior therapy can be included in this study
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Absolute neutrophil count (ANC) \>= 1500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Total bilirubin =\< 1.5 x upper limit of normal (ULN)
• Aspartate transaminase (AST) or alanine transaminase (ALT) =\< 3 x ULN
• Creatinine =\< 1.5 x ULN
• 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)
• Willing to provide blood samples for correlative research purposes

You may not qualify if:

• Any of the following:
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Results Point of Contact

• Title: Amit Mahipal MBBS
• Organization: Mayo Clinic

Mahipal.amit@mayo.edu

+1 (507) 293-0487

Study Officials

• Amit Mahipal

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: September 7, 2017
• First Posted: September 11, 2017
• Study Start: October 20, 2017
• Primary Completion: November 30, 2018
• Study Completion: September 16, 2021
• Last Updated: June 28, 2023
• Results First Posted: October 1, 2019

Record last verified: 2023-06

Locations

US (2)