TAS-102 in Combination With Oxaliplatin (TAS-OX) for Refractory Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Overall response rate
研究概览
简要总结
This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, 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.
详细描述
PRIMARY OBJECTIVE:
I. Overall response rate (ORR).
SECONDARY OBJECTIVES:
I. Progression free survival (PFS). II. Overall survival (OS). III. Disease control rate (DCR). IV. Duration of response. V. Safety and tolerability.
OUTLINE:
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
- •Histologically confirmed stage IV colon cancer (American Joint Committee on Cancer [AJCC] 7th edition) that has progressed after standard therapy that included fluorouracil (5-FU), irinotecan, oxaliplatin, bevacizumab (unless contraindicated) and an anti-EGFR antibody, if RAS wild type. Patients who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate
- •Patients who had received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen
- •Progression of disease must be documented on the most recent scan
- •Presence of measurable disease
- •RAS mutation and mismatch repair deficiency (MMR) status must be determined (or tissue availability for testing if not already determined)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Life expectancy of at least 3 months
- •Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- •Hemoglobin >= 9 g/dL
- •Platelets (PLT) >= 75 x 10^9/L
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x upper limit of normal (ULN)
- •Adequate contraception if applicable
- •Women who are nursing and discontinue nursing prior to enrollment in the program
- •Ability to take oral medication (i.e., no feeding tube)
- •Patient able and willing to comply with study procedures as per protocol
- •Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures
排除标准
- •Patients who have previously received TAS-102
- •Grade 2 or higher peripheral neuropathy (functional impairment)
- •Symptomatic central nervous system (CNS) metastases requiring treatment
- •Other active malignancy within the last 3 years (except for non-melanoma skin cancer or a non-invasive/in situ cancer)
- •Pregnancy or breast feeding
- •Current therapy with other investigational agents
- •Active infection with body temperature >= 38 degree Celsius (C) due to infection
- •Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to drug administration)
- •Any anticancer therapy within prior 3 weeks of first dose of study drug
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102
- •Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior 4 weeks
- •Grade 3 or higher hypersensitivity reaction to oxaliplatin, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication
- •Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity)
研究组 & 干预措施
Treatment (TAS-102, oxaliplatin)
Patients receive TAS-102 PO BID on days 1-5 and oxaliplatin IV over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Oxaliplatin (Drug)
Treatment (TAS-102, oxaliplatin)
Patients receive TAS-102 PO BID on days 1-5 and oxaliplatin IV over 2 hours 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
Overall response rate
时间窗: Up to 2 years
Response rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
次要结局
- Overall survival(Up to 2 years)
- Disease control rate(Up to 2 years)
- Progression free survival(From the date of start of treatment to the date of first documented progression or any cause of death during the study, assessed up to 2 years)
- Duration of response(Up to 2 years)
- Incidence of adverse events(Up to 28 days post treatment)
研究者
Howard S. Hochster, MD
Associate Director for Clinical Research Medical Oncology
Rutgers Cancer Institute of New Jersey