Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients (PACT-ACT-v6)
2016年3月11日 更新者:Helse Stavanger HF
A Novel Therapy for Locally Advanced and Metastatic Pancreatic Cancer Based on Nanoparticle Albumin-bound Paclitaxel and Gemcitabine: Circulating Tumor Cells as a Potential Biomarker for Treatment Monitoring, -Response and Survival
The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of diagnosis.
The prognosis is extremely poor with a 5-year survival rate of less than 5%.
Treatment with chemotherapy can improve efficacy, but still the median progression-free survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median overall survival is less than one year.
There is a urgent need for tools for predicting the efficacy of the treatment.
The current trial aims at investigating the biomarker potential of circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by gemcitabine and nab-paclitaxel.
研究概览
研究类型
介入性
注册 (预期的)
70
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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Stavanger、挪威、4068
- 招聘中
- Stavanger University Hospital
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接触:
- Bjørnar Gilje, MD, PhD
- 电话号码:+47 05151
- 邮箱:gibj@sus.no
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接触:
- Oddmund Nordgård, PhD
- 电话号码:+47 05151
- 邮箱:oddmundn@gmail.com
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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 至 80年 (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:
- Male or female > 18 years up to 80 years
- Histologically or cytologically proven adenocarcinoma of the pancreas before start of treatment. Also patients for whom there is a strong suspicion of unresectable pancreatic cancer will before the diagnosis is confirmed be asked for consent to take 2 additional biopsies at the time of diagnostic biopsy retrieval, in case the histological analysis confirms that they can be included.
- Locally advanced (primarily unresectable) and/or metastatic disease.
- Presence of at least one measurable lesion according to the RECIST criteria, not restricted to previously irradiated area or limited to bone, pleural effusion or ascites.
- ECOG/WHO performance status ≤2
- Absolute neutrophil count (ANC) >1.5 x 109 /L and platelet count >100 x 109/L
- Total bilirubin < 1.5 times the upper limit of the normal range at the institution (ULN) or AST or ALT < 2 x ULN. If liver metastases are present, patients can be included if total bilirubin < 5× ULN or AST/ALT <10× ULN. Dose reductions of paclitaxel will be performed when bilirubin >2xULN, depending on increase of the bilirubin level according to the recommendations of the Summary of Product Characteristics.
- Serum creatinin < 1,5 ULN / calculated creatine clearance > 60 ml/min.
- Written informed consent
Exclusion Criteria:
- Current infection, bowel obstruction or subobstruction, or other uncontrolled intercurrent illness.
- Prior medical treatment for advanced pancreatic cancer
- Confirmed brain metastasis.
- Concurrent or past history of another malignancy except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
- Treatment with any other investigational drug more than 30 days prior to study entry.
- Allergy to anyone of the included drugs.
- Female patient breast feeding or pregnancy
- Not able/ or not willing to use adequate contraception (defined below). A pregnancy test will be included in the baseline visit for women of childbearing potential.
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 |
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实验性的:Nab paclitaxel / gemcitabine
Patients will receive 125 mg per m2 nab-paclitaxel and 1000 mg per m2 on days 1, 8 and 15 followed by one week of rest before new treatment cycle.
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Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Change in levels of circulating tumor cells (CTCs) during treatment
大体时间:Baseline and 9 months
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Baseline and 9 months
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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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Post-baseline over-all survival
大体时间:Baseline and 9 months
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Baseline and 9 months
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Post-baseline disease-specific survival
大体时间:Baseline and 9 months
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Baseline and 9 months
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Post-baseline time to progression
大体时间:Baseline and 9 months
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Baseline and 9 months
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Clinical response to treatment by RECIST 1.1
大体时间:Baseline and 9 months
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Radiologic, clinical and biochemical assessment
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Baseline and 9 months
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Changes in quality of life during treatment
大体时间:Baseline and 9 months
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Quality of Life is assessed every 4 weeks during treatment and then every 8th weeks.
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Baseline and 9 months
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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。
调查人员
- 首席研究员:Bjørnar Gilje, MD, PhD、Helse Stavanger HF
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
2014年11月1日
初级完成 (预期的)
2017年6月1日
研究完成 (预期的)
2018年1月1日
研究注册日期
首次提交
2015年11月22日
首先提交符合 QC 标准的
2016年3月11日
首次发布 (估计)
2016年3月14日
研究记录更新
最后更新发布 (估计)
2016年3月14日
上次提交的符合 QC 标准的更新
2016年3月11日
最后验证
2016年3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.
Nab paclitaxel / gemcitabine的临床试验
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Fujian Cancer HospitalJiangsu Hengrui Pharmaceutical Co., Ltd.; SunWay Biotech Co., LTD.尚未招聘肝转移 | 恶性黑色素瘤
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Fondazione Policlinico Universitario Agostino Gemelli...招聘中
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Mati Therapeutics Inc.完全的