Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.
详细描述
This prospective phase II, single arm, single site trial will evaluate the efficacy of the combination of liposomal irinotecan (nal-IRI), TAS102, and bevacizumab for the treatment of patients with mismatch repair proficient, metastatic or unresectable colorectal cancer that has previously been treated with 5-fluorouracil, oxaliplatin, irinotecan and if RAS wild-type an anti-EGFR agent. A total of 25 patients will be accrued at UW Carbone Cancer Center. Subject enrollment will occur over 12 months with the total duration of the trial expected to be 3 years.
Primary Objective
- To determine the progression free survival (PFS) of patients with metastatic colorectal cancer treated in the treatment refractory setting with liposomal irinotecan in combination with TAS102 and bevacizumab.
Secondary Objectives
- To evaluate the objective response rate (ORR) of liposomal irinotecan in combination with bevacizumab and TAS102.
- To assess the safety and tolerability of these regimens in this setting.
- To determine the impact of the timing of irinotecan use in prior lines of therapy on the ORR and PFS observed with these nal-IRI containing treatment regimens
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
- •Patients must be ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance must be 0 or
- •Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable.
- •The cancer must be mismatch repair proficient.
- •Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior anti-EGFR therapy with either cetuximab or panitumumab. If RAS wild-type and HER2 positive then must have had a prior HER2 targeted therapy.
排除标准
- •Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy.
- •Patients whose cancers possess BRAF V600 mutations are excluded.
- •Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy.
- •Patients must not have mismatch repair deficient or microsatellite instability high cancers.
- •Patients must not have received prior TAS102.
研究组 & 干预措施
Participants with Metastatic or Unresectable Colorectal Cancer
Male and females aged 18 years and older with histologically confirmed metastatic or unresectable (not amenable to curative therapy) colorectal cancer.
干预措施: Liposomal irinotecan (Drug)
Participants with Metastatic or Unresectable Colorectal Cancer
Male and females aged 18 years and older with histologically confirmed metastatic or unresectable (not amenable to curative therapy) colorectal cancer.
干预措施: TAS102 (Drug)
Participants with Metastatic or Unresectable Colorectal Cancer
Male and females aged 18 years and older with histologically confirmed metastatic or unresectable (not amenable to curative therapy) colorectal cancer.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: up to 2 years
PFS is defined as the time from D1 of treatment with the study combination until the criteria for disease progression is met as defined by RECIST 1.1 criteria or death as a result of any cause.
次要结局
- Summary of Grade 3 and 4 Toxicities by Count of participants(up to 30 days post-treatment (approximately 6 months on study))
- Number of Participants Experiencing Grade 3 and 4 Toxicities(up to 30 days post-treatment (approximately 6 months on study))
- Objective Response Rate (ORR)(up to 2 years)
- Efficacy of irinotecan measured by PFS for patients with and without irinotecan containing regimens(up to 2 years)