Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
This phase II trial studies how well eribulin mesylate works in treating patients with advanced or recurrent cervical 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 OBJECTIVES:
I. To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or recurrent cervical cancer (progression-free survival [PFS].
SECONDARY OBJECTIVES:
I. To describe the toxicity profile of eribulin in patients with advanced or recurrent cervical cancer.
II. To estimate the survival of patients with advanced or recurrent cervical cancer treated with eribulin.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of invasive cervical cancer
- •Measurable disease
- •0-1 prior chemotherapy regimens for recurrent or advanced disease; platinum based chemotherapy administered as a radiation sensitizer agent is allowed and does not count as prior therapy
- •Absolute granulocyte count (AGC) >= 1,500
- •Platelet >= 100,000
- •Serum creatinine < 2.0 mg/dl
- •Bilirubin =< 1.5 times the upper limit of the normal range (ULN)
- •Alkaline phosphatase =< 3 x ULN (in the case of liver metastases, =< 5 x ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (in the case of liver metastases, =< 5 x ULN)
- •Peripheral neuropathy grade 0-2
- •Recovery of all chemotherapy or radiation-related toxicities to grade =< 1, except for alopecia and peripheral neuropathy
- •Performance status 0-2
- •Signed informed consent
排除标准
- •Prior treatment with eribulin
- •Chemotherapy, radiation, or biological or targeted therapy within 3 weeks
- •Hormonal therapy within 1 week
- •Any investigational drug within 4 weeks
- •Known brain metastases, unless previously treated and asymptomatic for 3 months and not progressive in size or number for 3 months
研究组 & 干预措施
Eribulin mesylate
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: eribulin mesylate (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 months
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death. It is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: At study drug administration until 30 days following the last dose. Assessed up to 2 years.
Safety evaluation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3 was used to grade all SAEs. Grade 3+ hematologic and non-hematologic toxicities are reported.
次要结局
- Best Overall Response (BOR)(Every 6 weeks from start of treatment until occurrence of progressive disease, assessed up to 4 years.)
- Overall Survival (OS)(From first day of treatment to time of death due to any cause, assessed up to 2 years)