Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
2017年12月15日 更新者：Merck Sharp & Dohme LLC
A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin
This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
68
阶段
- 阶段1
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:
- Has histologically or cytopathologically confirmed metastatic or locally advanced stage IIIB/IV Non-small cell lung cancer (NSCLC)
- Has measurable disease
- Has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for NSCLC
- Is 18 years of age or older
- Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Women of childbearing potential have a negative pregnancy test
Exclusion Criteria:
- Is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
- Has untreated brain metastases related to their NSCLC or carcinomatous meningitis
- Abuses drugs or alcohol
- Is pregnant or breastfeeding
- Is Human Immunodeficiency Virus (HIV) positive
- Has active viral hepatitis
- Has hearing loss
- Has poorly controlled diabetes mellitus
- Is allergic to gemcitabine, cisplatin or carboplatin
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：诊断
- 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：Gem/Cis or Gem/Carbo
|
Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.)
They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle.
Gemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle.
Two cycles are given 3 weeks apart.
|
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 |
|---|---|---|
|
Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
大体时间：Weeks 3 and 6 following chemotherapy
|
Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG).
The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
|
Weeks 3 and 6 following chemotherapy
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Repeatability of FDG SUVmean at Baseline
大体时间：Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
|
Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean.
The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
|
Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
|
|
Change in FDG-PET Uptake From Baseline to Week 3
大体时间：Baseline and Week 3
|
Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.
The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
|
Baseline and Week 3
|
|
Change in FDG-PET Uptake From Week 3 to Week 6
大体时间：Week 3 and Week 6
|
Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.
The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
|
Week 3 and Week 6
|
|
Change in FGD-PET Uptake From Baseline to Week 6
大体时间：Baseline and Week 6
|
Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass. |
Baseline and Week 6
|
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 (实际的)
2009年1月1日
初级完成 (实际的)
2010年6月10日
研究完成 (实际的)
2011年4月13日
研究注册日期
首次提交
2008年1月7日
首先提交符合 QC 标准的
2008年1月11日
首次发布 (估计)
2008年1月24日
研究记录更新
最后更新发布 (实际的)
2018年1月16日
上次提交的符合 QC 标准的更新
2017年12月15日
最后验证
2017年12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.