TAS-102 in Treating Advanced Biliary Tract Cancers

TAS-102 in Treating Advanced Biliary Tract Cancers

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https://clinicaltrials.gov/ct2/show/NCT03278106

Purpose
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.

Condition Intervention Phase
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
Other: Laboratory Biomarker Analysis
Drug: Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Trifluridine/Tipiracil (FTD/TPI (TAS-102)) in Biliary Tract Cancers

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma
Drug Information available for: Trifluridine
Genetic and Rare Diseases Information Center resources: Bile Duct Cancer Gallbladder Cancer Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
Progression-free survival rate defined as the proportion of evaluable patients who are progression-free (stable disease, partial response, complete response) [ Time Frame: 16 weeks ]
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson.

Secondary Outcome Measures:
Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events [ Time Frame: Up to 3 years ]
The maximum grade for each type of adverse event by patient will be summarized by frequencies and percentages.

Overall response rate (ORR) defined as the proportion of patients who experience either a partial response or complete response by the given time point [ Time Frame: Up to 3 years ]
ORR will be reported descriptively and a 95% confidence interval will be reported.

Overall survival (OS) [ Time Frame: Time from study entry to death from any cause, assessed up to 3 years ]
OS will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported.

Progression-free survival (PFS) determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria [ Time Frame: Time from study entry to the first of either disease progression or death from any cause, assessed up to 3 years ]
PFS will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported.

Other Outcome Measures:
Change in circulating tumor cells (CTCs) or cell-free deoxyribonucleic acid (DNA) (cfDNA) [ Time Frame: Baseline up to 3 years ]
Will correlate with efficacy endpoints.

Circulating tumor cells (CTCs) or cell-free deoxyribonucleic acid (DNA) (cfDNA) analysis at baseline [ Time Frame: Baseline ]
Will determine if CTCs or cfDNA at baseline will correlate with prognosis or response to therapy.

Mutation status of the tumor [ Time Frame: Up to 3 years ]
Will determine if different mutations status of the tumor will affect efficacy endpoints.

Estimated Enrollment: 28
Anticipated Study Start Date: September 15, 2017
Estimated Study Completion Date: September 15, 2020
Estimated Primary Completion Date: September 15, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (TAS-102)
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
Correlative studies
Drug: Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
Given PO
Other Names:
Lonsurf
TAS-102
Trifluridine/Tipiracil

Detailed Description:
PRIMARY OBJECTIVES:

I. Determine the efficacy of trifluridine/tipiracil hydrochloride combination agent TAS-102 (FTD/TPI [TAS-102]) in patients with refractory cholangiocarcinoma using progression-free survival at 16 weeks.

SECONDARY OBJECTIVES:

I. Assess the safety and tolerability of FTD/TPI (TAS-102) in patients with refractory cholangiocarcinoma through adverse event monitoring.

II. Further explore the efficacy of FTD/TPI (TAS-102) in patients with refractory cholangiocarcinoma by overall response rates, progression-free survival, and overall survival.

TERTIARY OBJECTIVES:

I. Determine if circulating tumor cells (CTCs) or cell-free deoxyribonucleic acid (DNA) (cfDNA) at baseline correlates with prognosis or response to therapy.

II. Determine if change in CTCs or cfDNA correlates with efficacy endpoints. III. Determine if different mutational status of the tumor will affect efficacy endpoints.

OUTLINE:

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

After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 2 years.

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

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
Exclusion Criteria:

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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03278106

Locations
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office 855-776-0015
Principal Investigator: Amit Mahipal
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Amit Mahipal Mayo Clinic
More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03278106 History of Changes
Other Study ID Numbers: MC1642
NCI-2017-01603 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1642 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
Study First Received: September 7, 2017
Last Updated: September 7, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Cholangiocarcinoma
Gallbladder Neoplasms
Biliary Tract Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 12, 2017