NCT04151277招募中2 期
PRIMUS 001: An Adaptive Phase II Study of FOLFOX-A (FOLFOX and Nab-paclitaxel) Versus AG (Nab-paclitaxel and Gemcitabine) in Patients With Metastatic Pancreatic Cancer, With Integrated Biomarker Evaluation
Judith Dixon-Hughes30 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年11月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 30
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is comparing two combinations of chemotherapy treatments in patients with metastatic pancreatic cancer. Half the participants will receive FOLFOX-A and the other half will receive AG. Treatment will continue until progression or patient/clinican decision or intolerable toxicity.
详细描述
PRIMUS 001 is a multicentre, randomised, open label, two arm, phase II interventional trial with pre-clinical and translational work including in-depth molecular profiling and biomarker discovery/development. The primary objective is to look at the efficacy of FOLFOX-A compared to AG in all comers and in a biomarker positive group using progression free survival.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been enrolled in the Precision-Panc Master Protocol
- •Patient has provided signed information consent for the PRIMUS 001 study
- •Age ≥ 16 years
- •Histologically-confirmed pancreatic ductal adenocarcinoma and its varients
- •Measurable metastatic disease according to RECIST V1.1
- •Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks
- •Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with a fluoropyrimidine and/or gemcitabine administered in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ongoing toxicities are present
- •Adequate liver/bone marrow function as defined by:
- •Neutrophils (ANC) ≥ 1.5 x 109/l
- •Platelets ≥ 100 x 109/l
- •Haemoglobin ≥ 9.0 g/dL
- •White Blood Cells (WBC) ≥ 3 x 109/l
- •Total bilirubin ≤ 1.5 x institutional ULN unless bilirubin rise is due to Gilbert's syndrome
- •Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN ( <5 ULN in the presence of liver metastases)
- •Estimated creatinine clearance ≥ 60 mL/min (as calculated by Cockcroft and Gault or Wright formula or measured by EDTA clearance)
- •Negative serum or urine Human Chorionic Gonadotropin (HCG) test for females with child bearing potential. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential
- •Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see s section 8.1.8.1) for the duration of the study and for up to 6 months after the completion of study treatment.
- •Compliant, and can be followed up regularly
- •The following additional inclusion criteria is ONLY required if recommended by the independent Data Monitoring Committee after interim review of study data (sites will have been informed by the Cancer Research UK (CRUK) Clinical Trials Unit (CTU) if this is the case)
- •Patient must be biomarker positive as fed back after central Precision-Panc diagnostic testing
排除标准
- •Prior treatment with nab-paclitaxel or oxaliplatin
- •Prior chemotherapy for metastatic pancreatic cancer
- •Known hypersensitivity for any component of any study drug
- •Active infection including Herpes Zoster and chickenpox
- •Current neuropathy ≥ grade 2
- •Uncontrolled brain metastasis
- •Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months
- •Uncontrolled serious contraindicated medical condition or illness
- •Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
- •Pregnant or breastfeeding
- •History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol
- •Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, of receiving the first dose of trial treatment
- •Any systemic anti-cancer therapy or major surgery within 28 days of randomisation
- •Any minor surgery or radiotherapy within 7 days of randomisation
- •Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule
- •Any patients receiving treatment with brivudin, sorivudin and analogues
- •History of another malignancy in the last 5 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically-stable organ-confined prostate cancer)
- •Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection)
研究组 & 干预措施
FOLFOX-A
Experimental
- nab-paclitaxel: 150mg/m2 IV over 30 minutes, day 1 (administered first)
- Oxaliplatin: 85mg/m2, IV over 2 hours, day 1
- Folinic acid: 350 mg flat dose, IV over 2 hours, day 1
- 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours (or 48 hours as per standard practice))
干预措施: FOLFOX-A (Drug)
FOLFOX-A
Experimental
- nab-paclitaxel: 150mg/m2 IV over 30 minutes, day 1 (administered first)
- Oxaliplatin: 85mg/m2, IV over 2 hours, day 1
- Folinic acid: 350 mg flat dose, IV over 2 hours, day 1
- 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours (or 48 hours as per standard practice))
干预措施: G-CSF (Drug)
Abraxane and Gemcitabine
Active Comparator
- nab-paclitaxel: 125 mg/m2 IV over 30 minutes, day 1, 8, and 15 (administered first)
- Gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 (immediately following nab-paclitaxel)
干预措施: Gemcitabe and Abraxane (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: At time of progression (estimated to be between 5 and 7.5 months)
Progression free survival as measured froim the date of randomisation to progression or death (from any cause)
次要结局
- Ojective Response Rate(Measured every 8 weeks by CT scan (most patients will received 3-4 CT scans over 24-32 weeks)))
- Overall Survival(From date of randomisation until date of death from any cause. Most patients with metastatic pancreatic cancer will die within 6-9 months from diagnosis)
- Safety and Tolerability of FOLFOX-A treatment(At every chemotherapy visit (every 2 weeks) - and at end of treatment visit (within 30 days of completing chemotherapy). Chemotherapy will continue until progression (estimated at between 5-7.5 months))
- Safety and Tolerability of AG treatment(At every chemotherapy visit (3 weeks out of every 4) - and at end of treatment visit (within 30 days of completing chemotherapy). Chemotherapy will continue until progression (estimated at between 5-7.5 months))
- Quality of Life (EORTC QLQ-C30)(Every 8 weeks while on treatment, at end of treatment visit, which will take place within 30 days of completing treatment, and at follow-up visits (6, 9, 12, 18, 24, 36, 48 and 60 months post randomisation).)
- Peripheral Neuropathy(Every 4 weeks while on treatment, at end of treatment visit and at follow-up visits (6, 9, 12, 18, 24, 36, 48 and 60 months post randomisation).)
- Health Economics as defined to hospital resource use i.e how many nights the patient has spent in hospital and how may times they have attended hospital since the last time they were seen(At each study visit. Patient will be followed up for up to 5 years post randomistation (6, 9, 12, 18, 24, 36, 48 and 60 months post randomisation).)
- Biomarker Discovery and Development(Ongoing during study. Recruitment will take 46 months and patients will be followed-up for up to 5 years post randomisation)
- Quality of Life (EORTC QLQ-PAN26)(Every 8 weeks while on treatment, at end of treatment visit, which will take place within 30 days of completing treatment, and at follow-up visits (6, 9, 12, 18, 24, 36, 48 and 60 months post randomisation).)
- Quality of Life (EQ-5D-5L)(Every 8 weeks while on treatment, at end of treatment visit, which will take place within 30 days of completing treatment, and at follow-up visits (6, 9, 12, 18, 24, 36, 48 and 60 months post randomisation).)
研究者
Judith Dixon-Hughes
Project Manager
University of Glasgow
研究点 (30)
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