A Study to Evaluate the Safety and Efficacy of Caelyx in Combination With Carboplatin in Patients With Ovarian Cancer Recurrent Within Six to Twelve Months After Initial Carboplatin and Paclitaxel Chemotherapy (P03625)
2017年5月12日 更新者:Merck Sharp & Dohme LLC
Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-free Interval) Relapsed Epithelial Ovarian Cancer.
Doxorubicin has been used to treat ovarian cancer as part of different combination therapies, but high cumulative doses should be avoided because of the risk of cardiotoxicity.
Pegylated Liposomal Doxorubicin (Caelyx) has been developed to reduce the risk of cardiotoxicity.
The purpose of this study is to evaluate the safety and efficacy of Caelyx in combination with carboplatin in women with recurrent ovarian cancer.
研究概览
研究类型
介入性
注册 (实际的)
58
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Age >=18 years old
- Subject must have histological diagnosis of epithelial ovarian cancer
- Subject must have received a taxane and platinum regimen and have maintained a treatment-free status for at least six months and not more than twelve months following completion of first line therapy.
- Subject must have measurable ovarian cancer by appropriate radiological imaging.
- ECOG performance Score of 0 or 1.
- Subject's life expectancy must be > 6 months.
Subject must have normal organ function, except if abnormal due to tumor involvement:
- Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=100 g/L, neutrophils >=1.5 X 10^9/L)
- Adequate renal function (serum creatinine<=1.5 X the upper limit of normal (ULN)
- Adequate liver function (bilirubin and AST or ALT<=2 times ULN, unless related to primary disease.
- MUGA scan must indicate left ventricular ejection fraction above 90%.
- Women of childbearing potential must be using adequate contraception (prescribed under medical supervision) and have a negative pregnancy test at the time of enrollment.
- Subject must be able to sign written informed consent.
Exclusion Criteria:
- Subject who is pregnant or is breast feeding.
- Subject who has history of cardiac disease, with New York Heart Association Class II or greater.
- Subject with a history of severe hypersensitivity reactions to products containing Cremophor® EL.
- Subject with clinically significant hepatic disease.
- Subject who has uncontrolled bacterial, viral, or fungal infection.
- Subject who exhibits confusion or disorientation.
- Subject with any condition that would prevent adequate follow-up.
- Subject with a history of prior malignancy treated with systemic chemotherapy or radiotherapy.
- Subject who has received two or more prior chemotherapy regimens for ovarian cancer.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Single Arm
Caelyx 30 mg/m2 in combination with carboplatin dosed to target AUC of 5 mg/mL.min.
|
Subjects will receive Caleyx 30 mg/m2 intravenously on Day 1 of each 4-week cycle, during 6 cycles.
Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
其他名称:
Subjects will receive carboplatin dosed to target AUC of 5 mg/mL.min,
intravenously, on Day 1 of each 4-week cycle, after the Caelyx infusion, during 6 cycles.
Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Complete response rate, according to RECIST criteria; Partial response rate, according to RECIST criteria
大体时间:Complete or partial response: re-evaluation 4 weeks later to confirm response; Upon completion of chemotherapy: follow-up every 2 months until documentation of progressive disease; All patients will be followed for a minimum of one year for survival
|
Complete or partial response: re-evaluation 4 weeks later to confirm response; Upon completion of chemotherapy: follow-up every 2 months until documentation of progressive disease; All patients will be followed for a minimum of one year for survival
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Safety and tolerability; Duration of response; CA-125 response; Time to progression; Overall survival
大体时间:All patients will be followed for a minimum of one year for survival
|
All patients will be followed for a minimum of one year for survival
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Li KJ, Garoff H. Packaging of intron-containing genes into retrovirus vectors by alphavirus vectors. Proc Natl Acad Sci U S A. 1998 Mar 31;95(7):3650-4. doi: 10.1073/pnas.95.7.3650.
- Power P, Stuart G, Oza A, Provencher D, Bentley JR, Miller WH Jr, Pouliot JF. Efficacy of pegylated liposomal doxorubicin (PLD) plus carboplatin in ovarian cancer patients who recur within six to twelve months: a phase II study. Gynecol Oncol. 2009 Sep;114(3):410-4. doi: 10.1016/j.ygyno.2009.04.037. Epub 2009 Jun 10.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2003年10月1日
初级完成 (实际的)
2007年9月6日
研究完成 (实际的)
2007年9月6日
研究注册日期
首次提交
2008年10月23日
首先提交符合 QC 标准的
2008年10月23日
首次发布 (估计)
2008年10月24日
研究记录更新
最后更新发布 (实际的)
2017年5月15日
上次提交的符合 QC 标准的更新
2017年5月12日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- P03625
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Pegylated Liposomal Doxorubicin的临床试验
-
National Cheng-Kung University HospitalNational Cheng Kung University; The Industrial Technology Research Institute完全的