EUCTR2016-001305-16-FR进行中（未招募）1 期
Assessment of the efficacy of bevacizumab in combination with Folfiri as second-line treatment after the failure of the cisplatin (or carboplatin)-etoposide combination in patients suffering from an advanced inoperable poorly differentiated neuroendocrine carcinoma of an unknown or gastroentero-pancreatic primary cancer. A phase 2 non-comparative randomized study. PRODIGE 41 - BEVANEC study - BEVANEC
Hospices Civils de Lyon - Direction de la Recherche Clinique et de l'Innovation0 个研究点开始时间: 2017年7月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Man or woman aged = 18 years old,
- •- Poorly differentiated neuroendocrine carcinoma (NEC) from a gastroentero-pancreatic (GEP) primary or an unknown primary cancer, locally advanced and/or metastatic (according to the WHO 2010),
- •- Centralized review of the diagnostic by a consulting pathologist specializing in NET (TENPATH network),
- •- Recommendation of a second-line chemotherapy after progression documented using the RECIST criteria v.1.1 and after a first-line chemotherapy treatment by cisplatin (or carboplatin) + etoposide or in the case of progression in the 6 months following the discontinuation of this first-line treatment,
- •- Patients presenting at least one measurable target lesion according to the RECIST criteria v.1.1, in an area not previously irradiated,
- •- General condition inferior or equal 2 (WHO),
- •- Patient who signed the informed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1) Relating to the tumor, the patient and the previous treatment:
- •- Well differentiated gastroentero-pancreatic neuroendocrine tumor (NET G1 and G2 according to the WHO 2010),
- •- Mixed tumor,
- •- First-line chemotherapy other than cisplatin (carboplatin) and etoposide,
- •- All malignant disease in the three year before randomization, with the exception of basal cell carcinoma or in situ cervical cancer treated for curative purposes,
- •- A pregnant or breastfeeding woman,
- •- Lack of efficient contraception (for men or women of reproductive age),
- •- All medical, geographical, social, and psychological conditions or a legal situation that will not allow the patient to finish the study or sign an informed consent form.
- •2) Relating to the chemotherapy (Folfiri):
- •- Any of the following uncontrolled progressive diseases in the 6 months before randomization: liver failure, renal insufficiency, respiratory distress, congestive heart failure (NYHA III-IV), unstable angina, myocardial infarction, significant arrhythmia,
- •- Known deficiency in dihydropyrimidine dehydrogenase,
- •- Known Gilbert's syndrome,
- •- Total bilirubin level >1.5x the upper limit of normal (ULN); AST and/or ALT >5x ULN; TP <50%;
- •- Neutrophils <1.5x109/l, platelets <100x109/l, hemoglobin <10 g/dl,
- •- Chronic uncontrolled diarrhea, unresolved intestinal occlusion or subocclusion,
- •- History of anaphylactic reaction or known intolerance to atropine (sulfate) or to loperamide or to antiemetics administered in association with Folfiri.
- •3) Relating to bevacizumab:
- •- Uncontrolled wound and important surgery within the last 28 days
- •- Uncontrolled brain metastases (by local treatment),
- •- All uncontrolled progressive disease within 1 month prior to randomization: grade 3-4 gastrointestinal bleeding (peptic ulcer, erosive esophagitis or gastritis), infectious disease or intestinal inflammation, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event,
- •- Uncontrolled high blood pressure, defined as a systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg,
- •- Patients receiving anticoagulant treatment with an unstable dose of a vitamin K antagonist treatment, and/or having an abnormal INR (>3) in the four weeks before the randomization,
- •- Verified proteinuria above or equal to 1g/24 hours measured from 24 hours of urine if the urinary protein dipstick control is above or equal to 2+,
- •- Creatinine clearance (MDRD) <50 ml/min.
- •- Hypersensitivity to the active substance or to any of the excipients.
- •- Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
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