EUCTR2016-001508-45-ES进行中（未招募）1 期
Phase II clinical trial to evaluate the efficacy of FOLFIRI + aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without ACE polymorphisms - POLAF
Grupo de Tratamiento de los Tumores Digestivos (TTD)0 个研究点目标入组 100 人开始时间: 2016年7月15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
- 入组人数
- 100
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
- •1. Informed consent form signed and dated, and willingness and ability to accomplish the protocol requirements.
- •2. Histologically confirmed Adenocarcinoma of the colon and / or rectum
- •3. Diagnosed metastatic disease.
- •4. Evidence of at least one measurable lesion using one-dimensional CT or MRI according to RECIST criteria, version 1.1.
- •5. Patients with metastatic colorectal cancer (MCRC) that is resistant or has progressed after treatment with oxaliplatin.
- •6. Age = 18 years.
- •7. Functional status (EF) of the World Health Organization (WHO) of 0 to 2.
- •8. Adequate bone marrow function: neutrophils (ANC) = 1.5 x 109 / l; platelets = 100 x
- •109 / l; hemoglobin = 9 g / dl.
- •9. Adequate renal function: serum creatinine level <1.5 times the upper limit of normal (ULN).
- •10. Adequate liver function: serum bilirubin = 1.5 times the ULN, alkaline phosphatase (AP) <5 ULN.
- •11. Proteinuria <2+ (urine dipstick test) or = 1 g / 24 hours.
- •12. Feasibility of performing regular monitoring
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Uncontrolled hypercalcemia.
- •2. Pre-existing permanent Neuropathy (NCI grade> 2).
- •3. Uncontrolled hypertension (defined as systolic blood pressure > 150 mm Hg and / or diastolic blood pressure> 100 mm Hg) or history of hypertensive crisis or hypertensive encephalopathy.
- •4. Concomitant antineoplastic treatment non-scheduled in the protocol (e.g., chemotherapy, targeted molecular therapy, immunotherapy).
- •5. Treatment with any other investigational product within 28 days prior to inclusion in the study.
- •6. Another serious and uncontrolled non-malignant disease
- •7. History or evidence of CNS metastases on physical examination, unless it is properly treated (e.g., non-irradiated CNS metastases, convulsion uncontrolled with standard medical treatment).
- •8. Diagnosis of Gilbert's syndrome.
- •9. Atropine sulfate or loperamide intolerance.
- •10. Diagnosis of dihydropyrimidine dehydrogenase deficiency.
- •11. Treatment with inducers of CYP3A4, unless it is suspended> 7 days before inclusion.
- •12. Any of the following conditions in the 3 months prior to the screening visit: gastrointestinal hemorrhage grade 3 - 4 (unless it is caused by tumor extirpation), peptic ulcer resistant to treatment, esophagitis or erosive gastritis, infectious or inflammatory bowel disease or diverticulitis.
- •13. Other concomitant or previous malignant neoplasia, except for: i / Carcinoma in situ of the uterine cervix properly treated, ii / spinocellular or basal skin cell carcinoma, iii / cancer in complete remission for> 5 years.
- •14. Any other non-malignant and uncontrolled serious disease, major surgery or traumatic injury in the last 28 days.
- •15. Pregnant or during breast-feeding period.
- •16. Patients with known allergy to any component of the study drugs.
- •17. History of myocardial infarction and / or stroke in the previous 6 months before inclusion, congestive heart failure NYHA class III and IV.
- •18. Intestinal obstruction.
研究者
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