Stage IV Distal Bile Duct Cancer AJCC v8 Clinical Trial
Official title:
Phase II Trial of Trifluridine/Tipiracil in Combination With Irinotecan in Biliary Tract Cancers
| Verified date | July 2023 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | August 13, 2021 |
| Est. primary completion date | August 13, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic | National Comprehensive Cancer Network |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (cfDNA) at Baseline | Will determine if CTCs or cfDNA at baseline will correlate with prognosis or response to therapy. | Baseline | |
| Other | Change in CTCs or cfDNA | Will determine if change in CTCs or cfDNA will correlate with efficacy endpoints. | Baseline up to 20 months | |
| Other | Correlation of Response | Will determine if drug response from a parallel ex vivo trial using patient-derived tumor organoid correlates with clinical response to trifluridine and tipiracil hydrochloride (trifluridine/tipiracil) plus irinotecan hydrochloride (irinotecan). | Up to 20 months | |
| Other | Prediction of Clinical Benefit by Thymidine Kinase 1 (TK1) | Will evaluate the role of TK1 in predicting the clinical benefit of trifluridine/tipiracil plus irinotecan and discover potential mechanisms of resistance using patient-derived tumor organoid and pre-treatment biopsy specimen. | Baseline | |
| Primary | 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 | Overall Response Rate (ORR) | Will be defined as the proportion of patients who experience either a partial response or complete response as their best response. ORR will be reported descriptively and a 95% confidence interval will be reported. | Up to 20 months | |
| Secondary | Disease Control Rate (DCR) | Will be defined as the proportion of patients who experience a partial response, complete response, or have stable disease as their best response. DCR will be reported descriptively and a 95% confidence interval will be reported. | Up to 20 months | |
| Secondary | PFS | Will be determined based on RECIST v 1.1. PFS will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported. Patients will be censored at the last disease assessment date. | From study entry to the first of either disease progression or death from any cause, assessed up to 20 months | |
| Secondary | Overall Survival (OS) | Will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported. Patients will be censored at the date patient was last known to be alive. | From study entry to death from any cause, assessed up to 20 months | |
| Secondary | Number of Participants With Adverse Events | The maximum grade for each type of adverse event by patient will be summarized by frequencies and percentages using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. | Up to 28 days |
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|---|---|---|---|
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