A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 381
- 试验地点
- 1
- 主要终点
- Effects of perifosine on time to progression
研究概览
简要总结
This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone.
The effects of perifosine may be manifested by increased time to progression, tumor regression reflected in partial or complete responses, or a combination of these outcomes. The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression.
详细描述
This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. If there is any evidence of improved time to progression in any tumor type with any of the drugs to be evaluated, the initial study or component(s) of the study will be expanded to increase the certainty that this is an effect of perifosine. If there is compelling evidence of benefit from this study, a phase 3 trial will be conducted to obtain proof of principle.
Primary Study Objectives:
To determine the time to tumor progression when receiving single agent chemotherapy (capecitabine) in combination with perifosine in comparison to patients receiving single agent chemotherapy (capecitabine) alone (i.e., with placebo).
Secondary Study Objectives:
- To determine the toxicity of single agent chemotherapy in combination with perifosine.
- To compare the time to progression of chemotherapy in combination with placebo to historical experience.
- Overall survival will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •In the opinion of the treating physician, treatment with one of the following regimens should represent an appropriate treatment for the patient.
- •Capecitabine 825 mg/m2 BID days 1 - 14 q 3 weeks
- •Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.
- •Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.
- •ECOG performance status 0 or
- •Leukocytes >= 4,000/μL
- •absolute neutrophil count >= 1,500/ μL
- •platelets >= 100,000/ μL
- •HCT > 28% (with or without growth factor support)
- •Creatinine <= 2.5 mg/dl
- •total bilirubin < 1.5 x upper limit of normal
- •transaminase < 2.5 x upper limit of normal
- •Patients must have recovered from acute toxicity-excluding alopecia-related to prior therapy, including surgery or radiotherapy.
- •Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.
- •Patients must have ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients receiving any other investigational agents or devices.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements.
- •HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study due to potential pharmacokinetic interactions with perifosine.
- •Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Assoc. class II - IV congestive heart failure.
- •Female patients who are pregnant or lactating are ineligible.
研究组 & 干预措施
Arm 1: Perifosine + Capecitabine
Perifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
干预措施: Perifosine (Drug)
Arm 1: Perifosine + Capecitabine
Perifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
干预措施: Capecitabine (Drug)
Arm 2: Perifosine Placebo + Capecitabine
Perifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
干预措施: Capecitabine (Drug)
Arm 2: Perifosine Placebo + Capecitabine
Perifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
干预措施: Perifosine Placebo (Other)
结局指标
主要结局
Effects of perifosine on time to progression
时间窗: Every 12 weeks
Time to progression will be measured from the first day of study drug until progression.
次要结局
- Toxicity(Every 12 weeks)
- Comparison of time to progression to historical experience(Every 12 weeks)