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Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

2015年3月30日 更新者：Sanofi

Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

  • To assess disease progression free rate at 12 weeks
  • To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
  • To assess Overall Survival (OS)
  • To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
  • To assess the Health-Related Quality of Life (HRQoL)

研究概览

地位

完全的

条件

干预/治疗

详细说明

Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.

All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.

研究类型

介入性

注册 (实际的)

179

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

  • 乌克兰
      • Dnipropetrovsk、乌克兰、49102
        • Investigational Site Number 804002
      • Donetsk、乌克兰、83092
        • Investigational Site Number 804004
      • Lviv、乌克兰、70031
        • Investigational Site Number 804001
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、115478
        • Investigational Site Number 643001
      • St-Petersburg、俄罗斯联邦、197758
        • Investigational Site Number 643005
      • Tula、俄罗斯联邦、300053
        • Investigational Site Number 643006
      • Yaroslavl、俄罗斯联邦、150054
        • Investigational Site Number 643003
  • 加拿大
      • Montreal、加拿大、H3T 1E2
        • Investigational Site Number 124003
      • Oshawa、加拿大、L1G 2B9
        • Investigational Site Number 124002
      • Rimouski、加拿大、G5L 5T1
        • Investigational Site Number 124004
      • Toronto、加拿大、M5G 2M9
        • Investigational Site Number 124001
  • 匈牙利
      • Budapest、匈牙利、1121
        • Investigational Site Number 348001
      • Budapest、匈牙利、1121
        • Investigational Site Number 348004
      • Budapest、匈牙利、1125
        • Investigational Site Number 348002
      • Törökbálint、匈牙利、2045
        • Investigational Site Number 348003
  • 大韩民国
      • Seoul、大韩民国、120-752
        • Investigational Site Number 410001
      • Seoul、大韩民国、135-710
        • Investigational Site Number 410003
      • Seoul、大韩民国、138-736
        • Investigational Site Number 410002
  • 巴西
      • Porto Alegre、巴西、90610-000
        • Investigational Site Number 076001
  • 希腊
      • Athens、希腊、11522
        • Investigational Site Number 300005
      • Athens、希腊、11527
        • Investigational Site Number 300003
      • Heraklion、希腊、71110
        • Investigational Site Number 300001
      • Thessaloniki、希腊、54629
        • Investigational Site Number 300002
      • Thessaloniki、希腊、57010
        • Investigational Site Number 300004
  • 德国
      • Großhansdorf、德国、22927
        • Investigational Site Number 276003
      • Löwenstein、德国、74245
        • Investigational Site Number 276006
  • 意大利
      • Genova、意大利、16132
        • Investigational Site Number 380001
      • Livorno、意大利、57123
        • Investigational Site Number 380002
      • Novara、意大利、28100
        • Investigational Site Number 380005
      • Parma、意大利、43100
        • Investigational Site Number 380004
  • 挪威
      • Oslo、挪威、0440
        • Investigational Site Number 578001
      • Stavanger、挪威、4011
        • Investigational Site Number 578003
      • Trondheim、挪威、7006
        • Investigational Site Number 578002
  • 智利
      • Santiago、智利、8380456
        • Investigational Site Number 152001
      • Santiago、智利
        • Investigational Site Number 152005
  • 法国
      • Brest、法国、29609
        • Investigational Site Number 250005
      • Caen Cedex、法国、14033
        • Investigational Site Number 250004
      • La Tronche、法国、38700
        • Investigational Site Number 250006
      • Lille、法国、59800
        • Investigational Site Number 250002
      • Saint-Herblain Cedex、法国、44805
        • Investigational Site Number 250003
      • Villejuif Cedex、法国、94805
        • Investigational Site Number 250007
  • 波兰
      • Gdansk、波兰、80-952
        • Investigational Site Number 616004
      • Lublin、波兰、20-954
        • Investigational Site Number 616003
      • Poznan、波兰、60-569
        • Investigational Site Number 616002
      • Warszawa、波兰、02-781
        • Investigational Site Number 616001
  • 罗马尼亚
      • Cluj Napoca、罗马尼亚、400015
        • Investigational Site Number 642003
      • Cluj-Napoca、罗马尼亚、400015
        • Investigational Site Number 642005
      • Craiova、罗马尼亚、200385
        • Investigational Site Number 642001
      • Timisoara、罗马尼亚
        • Investigational Site Number 642002
  • 美国
    • Alabama
      • Muscle Shoals、Alabama、美国、35661
        • Investigational Site Number 840007
    • Nebraska
      • Omaha、Nebraska、美国、68114
        • Investigational Site Number 840005
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Investigational Site Number 840006
    • Ohio
      • Middletown、Ohio、美国、45042
        • Investigational Site Number 840003
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Investigational Site Number 840001
  • 西班牙
      • Badalona、西班牙、08916
        • Investigational Site Number 724002
      • Barcelona、西班牙、08035
        • Investigational Site Number 724004
      • Málaga、西班牙、29010
        • Investigational Site Number 724005
      • Valencia、西班牙、46026
        • Investigational Site Number 724001

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

全部

描述

Inclusion criteria :

  • Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy
  • Male or female greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)
  • Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1

Exclusion criteria:

  • Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study
  • More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes
  • Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)
  • Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization
  • Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included
  • Participants with known leptomeningeal metastases
  • History of other, invasive neoplasm requiring ongoing therapy
  • Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack
  • Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results
  • Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)
  • Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
  • Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation
  • History of hypersensitivity to polysorbate 80

  • Inadequate organ and bone marrow function as evidenced by:

    • Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)
    • Absolute neutrophil count <1.5 x 10^9 per liter
    • Platelet count <100 x 10^9 per liter
    • Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)
    • Alkaline Phosphatase (AP) >2.5 x ULN. In case of liver metastases AP >5 x ULN
    • Total bilirubin >1.0 x ULN
    • Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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
实验性的：卡巴他赛
药品：Cabazitaxel
Cabazitaxel 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
其他名称：
  • XRP6258
有源比较器：拓扑替康
药品：Topotecan
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

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
Progression Free Survival (PFS)
大体时间：Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)

次要结果测量

结果测量
措施说明
大体时间
Overall Survival
大体时间：From randomization to date of death (maximum 15 months)
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.
From randomization to date of death (maximum 15 months)
Progression Free Rate at Week 12
大体时间：Week 12
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.
Week 12
Overall Objective Tumor Response Rate
大体时间：Randomization to disease progression/occurrence (maximum 7.6 months)
Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.
Randomization to disease progression/occurrence (maximum 7.6 months)

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。

赞助

Sanofi

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

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

2012年3月1日

初级完成 (实际的)

2014年4月1日

研究完成 (实际的)

2014年4月1日

研究注册日期

首次提交

2011年12月22日

首先提交符合 QC 标准的

2011年12月27日

首次发布 (估计)

2011年12月28日

研究记录更新

最后更新发布 (估计)

2015年4月13日

上次提交的符合 QC 标准的更新

2015年3月30日

最后验证

2015年3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

  • ARD12166
  • 2011-003415-31 (EudraCT编号)
  • U1111-1123-3503 (其他标识符：UTN)

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.

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