A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
2014年11月25日 更新者：Hoffmann-La Roche
A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer.
The anticipated time on study treatment is 3-12 months.
研究概览
研究类型
介入性
注册 (实际的)
149
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kazan、俄罗斯联邦、420029
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Moscow、俄罗斯联邦、125284
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Moscow、俄罗斯联邦、105203
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Moscow、俄罗斯联邦、115478
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Moscow、俄罗斯联邦、143423
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Moscow、俄罗斯联邦、117837
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Saint-Petersburg、俄罗斯联邦、197022
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St Petersburg、俄罗斯联邦、197758
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Tomsk、俄罗斯联邦、634028
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Alberta
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Calgary、Alberta、加拿大、T2N 4N2
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British Columbia
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Kelowna、British Columbia、加拿大、V1Y 5L3
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Vancouver、British Columbia、加拿大、V5Z 4E6
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Budapest、匈牙利、1122
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Debrecen、匈牙利、4032
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Gyor、匈牙利、9024
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Emilia-Romagna
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Parma、Emilia-Romagna、意大利、43100
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Lombardia
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Milano、Lombardia、意大利、20133
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Bruxelles、比利时、1000
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Leuven、比利时、3000
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Wilrijk、比利时、2610
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Poznan、波兰、60-535
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Warszawa、波兰、02-781
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Birmingham、英国、B18 7QH
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London、英国、W12 OHS
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Manchester、英国、M20 4BX
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Plymouth、英国、PL6 8DH
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Sutton、英国、SM2 5PT
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Yeovil、英国、BA21 4AT
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Amsterdam、荷兰、1081 HV
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Amsterdam、荷兰、1066 CX
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Barcelona、西班牙、08036
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Barcelona、西班牙、08035
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Madrid、西班牙、28041
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Valencia、西班牙、46009
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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:
- histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
- only 1 previous regimen, which must be platinum-based;
- platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.
Exclusion Criteria:
- previous radiotherapy;
- previous treatment with an anti-cancer vaccine or any targeted therapy;
- major surgery or traumatic injury within 4 weeks of study;
- history or evidence of central nervous system metastases.
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：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：化疗
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175 mg/m2 IV every 3 weeks for 6 cycles
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
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实验性的：Chemotherapy + Pertuzumab
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Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
175 mg/m2 IV every 3 weeks for 6 cycles
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Disease Progression or Death
大体时间：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants.
Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Progression-Free Survival
大体时间：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier.
Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants.
Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Kaplan-Meier Probability of No Disease or Progression at 1 Year
大体时间：1 year
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The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
大体时间：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR).
For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline.
Response according to CA 125 levels was defined as at least a 50% reduction from baseline.
The decrease had to be confirmed and maintained for at least 28 days.
The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%).
For overall response, the response categories were "response", "stable disease" and "progressive disease".
Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Duration of Response
大体时间：Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death.
Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.
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Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
大体时间：1 year
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1 year
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Percentage of Participants With Disease Progression
大体时间：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants.
Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Time to Progressive Disease
大体时间：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria.
Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Kaplan-Meier Probability of Being Progression Free at 1 Year
大体时间：1 year
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1 year
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Time To Response
大体时间：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease.
If response was evaluable by both criteria, then the date of response was for the earlier of the two events.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Percentage of Participants Who Died
大体时间：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Overall Survival
大体时间：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Survival was the interval of time from date of first dose of study medication to date of death at any time.
Participants who had not died were censored at the date of last contact when they were known to be alive.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Kaplan-Meier Probability of Being Alive at 1 Year
大体时间：1 year
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1 year
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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。
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
2005年12月1日
初级完成 (实际的)
2008年9月1日
研究完成 (实际的)
2008年9月1日
研究注册日期
首次提交
2013年12月3日
首先提交符合 QC 标准的
2013年12月3日
首次发布 (估计)
2013年12月6日
研究记录更新
最后更新发布 (估计)
2014年12月4日
上次提交的符合 QC 标准的更新
2014年11月25日
最后验证
2014年11月1日
更多信息
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.