Phase II Trial of Trifluridine/Tipiracil in Combination With Irinotecan in Biliary Tract Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. Determine the efficacy of trifluridine and tipiracil hydrochloride (trifluridine/tipiracil) in combination with irinotecan hydrochloride (irinotecan) in patients with refractory biliary tract cancers using progression-free survival (PFS) at 16 weeks.
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of trifluridine/tipiracil in combination with irinotecan in patients with refractory biliary tract cancers through adverse event monitoring.
II. Further explore the efficacy of trifluridine/tipiracil in combination with irinotecan in patients with refractory biliary tract cancers by overall response rates (ORR), disease control rates (DCR), and overall survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (trifluridine and tipiracil, irinotecan)
Patients 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.
干预措施: Irinotecan (Drug)
Treatment (trifluridine and tipiracil, irinotecan)
Patients 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.
干预措施: Irinotecan Hydrochloride (Drug)
Treatment (trifluridine and tipiracil, irinotecan)
Patients 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.
干预措施: Trifluridine and Tipiracil Hydrochloride (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to 16 weeks
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.
次要结局
- Overall Survival (OS)(From study entry to death from any cause, assessed up to 20 months)
- 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)
- Number of Participants With Adverse Events(Up to 28 days)