NCT02504333已完成1 期
A Phase I/II Study of Nab-paclitaxel (Abraxane) and Gemcitabine Followed by Modified FOLFOX (AG-mFOLFOX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Rate of overall survival al 12 months
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically confirmed pancreatic adenocarcinoma
- •Stage IV disease (metastatic only)
- •No prior systemic therapy for their diagnosis (except in adjuvant/neoadjuvant setting>six months previously)
- •ECOG performance status of 0-1
- •At least 18 years of age
- •Evidence of either or both of the following RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)
- •Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.
- •Adequate bone marrow function:
- •ANC ≥ 1500/uL
- •platelet count ≥ 100,000/uL
- •hemoglobin ≥ 9.0 g/dL
- •Adequate hepatic function:
- •Total bilirubin ≤ 1.5 X ULN
- •AST (SGOT) ≤ 2.5 X ULN
- •ALT (SGPT) ≤ 2.5 X ULN
- •Adequate renal function as determined by either:
- •Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
- •Ability to understand the nature of this study protocol and give written informed consent.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
- •Presence of central nervous system or brain metastases.
- •Life expectancy < 12 weeks
- •Pregnancy (positive pregnancy test) or lactation.
- •Pre-existing sensory neuropathy > grade
- •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- •Major surgery and/or radiotherapy within 4 weeks of the start of study treatment, without complete recovery.
- •Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
研究组 & 干预措施
AG
Active Comparator
nab-Paclitaxel followed by Gemcitabine
干预措施: nab-paclitaxel (Drug)
AG
Active Comparator
nab-Paclitaxel followed by Gemcitabine
干预措施: gemcitabine (Drug)
AG-mFOLFOX
Experimental
nab-Paclitaxel followed by Gemcitabine and FOLFOXm at dose levels selected from the phase I trial
干预措施: m-FOLFOX (Drug)
AG-mFOLFOX
Experimental
nab-Paclitaxel followed by Gemcitabine and FOLFOXm at dose levels selected from the phase I trial
干预措施: nab-paclitaxel (Drug)
AG-mFOLFOX
Experimental
nab-Paclitaxel followed by Gemcitabine and FOLFOXm at dose levels selected from the phase I trial
干预措施: gemcitabine (Drug)
结局指标
主要结局
Rate of overall survival al 12 months
时间窗: 12 weeks
Primary outcome phase II
Dose-limiting toxicity for the AG-mFOLFOX combination
时间窗: 12 weeks
Primary outcome phase I.
次要结局
- Rate of overall survival at 6 months(54 months)
- CA 19-9 biomarker response(54 months)
- Time to tumor progression(54 months)
- Progression free survival(54 months)
- Objective radiographic response(54 months)
- Rate of overall survival at 24 months(54 months)
- Overall Survival(54 months)
- Safety profile of this combination (AG-mFOLFOX) using NCI-CTCAE v.4 criteria(54 months)
- To assess the Quality of Life of the patients through the EORTC QLQ-C30/PAN26 and EORTC QLQ-CIPN20 questionnaires(54 months)
研究者
研究点 (1)
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