Phase II Trial of Thalidomide and Doxil® (Doxorubicin HCL Liposome Injection) in Patients With Androgen Independent Prostate Cancer (AIPC) With a Rising PSA While on Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease 2) To evaluate overall survival for this combination.
详细描述
This is an open label, Phase II trial of thalidomide and Doxil in patients with androgen independent prostate cancer whom have a rising PSA while on chemotherapy. The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease (If measurable soft tissue lesions are present on radiological or clinical exam) ; 2) To evaluate overall survival for this combination. There will be between 18 and 35 subjects at least 18 years of age enrolled on this single site study.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Confirmed androgen independent prostate cancer with evidence of rising PSA (two successive increases in PSA, at least 4 weeks apart) while on chemotherapy. If the PSA is less than 5, the increase in PSA must be at least 50%. Must also have castrate testosterone levels (<50 ng/ml)
- •Patients could not have received more than 2 previous chemotherapy regimens.
- •No anthracyclines within the past 6 months.
- •No prior single agent thalidomide in the last 12 months. No prior cytotoxic chemotherapy + thalidomide given in conjunction
- •Age > 18 years of age
- •Performance status ECOG 0-2
- •Peripheral neuropathy must be < grade 1
- •Must have adequate hematologic, hepatic and renal function
- •Men of reproductive potential must be willing to consent to using effective contraception while on treatment and for at least 4 weeks thereafter
- •Patients must have left ventricular ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring
- •Must have been off an anti-androgen for at least 4-6 weeks (Flutamide and Bicalutamide respectively) and documented as having a rising PSA
- •Measurable or evaluable disease (PSA elevation will constitute evaluable disease). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques CT scan or as >10 mm with spiral CT scan. See section 6.B for the evaluation of measurable disease
- •Life expectancy of greater than 3 months
- •Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program
- •Ability to understand and sign written informed consent approved by the Institutional Review Board [IRB/Ethics Committee], which will be obtained prior to study entry.
排除标准
- •Patients with unstable angina, uncompensated CHF, a history of an MI, PE or DVT within the last 3 months
研究组 & 干预措施
thalidomide and doxil
Combination of Thalidomide and Doxil
干预措施: Thalidomide (Drug)
thalidomide and doxil
Combination of Thalidomide and Doxil
干预措施: Doxil (Drug)
结局指标
主要结局
Response Rate
时间窗: 24 weeks
The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.
次要结局
- Overall Survival(36 months)
- Best Overall PSA Response(4 weeks)
- Time to Progression(Up to 18 months)