A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Objective Response (Complete and Partial) Evaluated Using RECIST Criteria
研究概览
简要总结
This phase II trial is studying how well E7389 works as second-line therapy in treating patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
详细描述
PRIMARY OBJECTIVE:
I. To determine the objective response (complete and partial) to E7389 in patients with locally advanced, unresectable, or metastatic pancreatic adenocarcinoma that progressed after prior gemcitabine hydrochloride-based therapy.
SECONDARY OBJECTIVE:
I. To determine the antitumor activity of E7389, in terms of median survival, 1-year survival rate, response or stable disease duration, toxicity, and time to disease progression, in these patients.
OUTLINE: This is an open-label, multicenter study. Patients receive eribulin mesylate IV on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
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/cytologically confirmed pancreatic carcinoma (locally advanced, unresectable or metastatic)
- •measurable disease (at least 1 lesion accurately measured in at least 1 dimension (longest diameter as >20mm with conventional techniques or >10mm with spiral CT scan)
- •>=4 weeks from any major surgery
- •Up to 1 prior line of gemcitabine based systemic therapy (single agent/combination therapy) for locally advanced/metastatic disease with evidence of disease progression. Prior therapy with inhibitors of angiogenesis and/or the epidermal growth factor receptor permitted. Last chemotherapy dose >=4 weeks prior to randomization.
- •May have received prior 5FU (+/- folinic acid)/gemcitabine given concurrently with radiation as a "radiation sensitizer". Last chemotherapy dose >=4 weeks prior to randomization.
- •Prior radiation treatment >=4 weeks prior to randomization
- •Age >18 years.
- •Life expectancy >=3 months
- •ECOG< 2(Karnofsky-60%)
- •leukocytes>3,000/mcL
- •absolute neutrophil count>1,500/mcL
- •platelets>100,000/mcL
- •total bilirubin < 1.5 UNL
- •AST/ALT≤2.5x institutional ULN
- •creatinine within institution limits OR creatinine clearance>60mL/min/1.73m2 for patients with creatinine levels above institution limits
- •concurrent use of inhibitors/inducers of CYP3A4 are prohibited during the study treatment period
- •effects of E7389 on developing human fetus are unknown. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- •Ability to understand/willingness to sign written informed consent
排除标准
- •chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •May not be receiving other investigational agents
- •Known brain metastases
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to E7389
- •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
- •Pregnant women excluded because E7389 is an antitubulin agent with the potential for teratogenic/abortifacient effects
- •HIV-positive patients on combination antiretroviral therapy are ineligible because of potential for p PK interactions with E7389
- •Other active malignancies in past 5 years except for cervical carcinoma in situ and non-melanomatous skin cancer
研究组 & 干预措施
Treatment (eribulin mesylate)
Patients receive E7389 IV on days 1 and 8.
干预措施: eribulin mesylate (Drug)
结局指标
主要结局
Objective Response (Complete and Partial) Evaluated Using RECIST Criteria
时间窗: Up to 3 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
次要结局
- Overall Survival(At 1 year)
- Toxicity(All patients will be evaluable for toxicity from the time of their first treatment with E7389.)
- Response Duration(From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years)
- Stable Disease Rate, Evaluated Using RECIST Criteria(Up to 3 years)
- Median Survival Time(Up to 3 years)
- Time to Progression(At 1 year)
- Median Time to Disease Progression(Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years)
- Objective Stable Disease Rate(Upto 3 years)