NCT02970916已完成2 期
A Phase II Trial to Assess FOLFIRI+Aflibercept Efficacy in Patients With Oxaliplatin-pretreated Metastatic Colorectal Cancer With or Without ACE Polymorphisms
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 100 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- FOLFIRI+aflibercept efficacy in terms of Progression-free survival (PFS) with or without ACE polymorphisms.
研究概览
简要总结
The purpose of this study is to assess FOLFIRI+aflibercept efficacy in patients with or without ACE polymorphisms in terms of Progression-free survival (PFS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed and dated informed consent, and willing and able to comply with protocol requirements,
- •Histologically proven adenocarcinoma of the colon and/or rectum,
- •Metastatic disease confirmed.
- •Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1
- •Patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
- •Age ≥18 years
- •World Health Organization (WHO) Performance status (PS) 0-2,
- •Hematological status: neutrophils (ANC) ≥1.5x109 /L; platelets ≥100x109 /L; haemoglobin ≥9g/dL
- •Adequate renal function: serum creatinine level < 1.5 x ULN
- •Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alkaline phosphatase (ALP) <5xULN
- •Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour.
- •Regular follow-up feasible.
- •For female patients of childbearing potential, negative serum pregnancy test
- •Female patients must commit to using reliable and appropriate methods of contraception until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial.
排除标准
- •Uncontrolled hypercalcemia,
- •Pre-existing permanent neuropathy (NCI grade >2)
- •Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive ncephalopathy,
- •Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- •Treatment with any other investigational medicinal product within 28 days prior to study entry.
- •Other serious and uncontrolled non-malignant disease,
- •History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
- •Known Gilbert's syndrome
- •Intolerance to atropine sulfate or loperamide
- •Known dihydropyrimidine dehydrogenase deficiency
- •Treatment with CYP3A4 inducers unless discontinued > 7 days prior to inclusion
- •Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis.
- •Other concomitant or previous malignancy, except: i/ adequately treated insitu carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
- •Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
- •Pregnant or breastfeeding women,
- •Patients with known allergy to any excipient to study drugs,
- •History of myocardial infarction and/or stroke within 6 months prior to inclusion, NYHA class III and IV congestive heart failure
- •Bowel obstruction.
研究组 & 干预措施
FOLFIRI+aflibercept
Experimental
干预措施: FOLFIRI+aflibercept (Drug)
结局指标
主要结局
FOLFIRI+aflibercept efficacy in terms of Progression-free survival (PFS) with or without ACE polymorphisms.
时间窗: 30 months
次要结局
- Progression free survival (PFS) with or without AGTR1 polymorphisms, according Serum-level sACE(30 months)
- Objective Response Rate (ORR) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE(30 months)
- Disease Control Rate (DCR) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE(30 months)
- Time to progression (TP) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE(30 months)
- Time to treatment failure (TTF) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE(30 months)
- Overall survival (OS) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE(30 months)
- Number of participants with adverse events as assessed by CTCAE v4.0.(30 months)
研究者
研究点 (1)
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