EUCTR2013-002567-26-GR进行中（未招募）1 期
Single-arm phase II study of maintenance therapy with aflibercept after first-line treatment with FOLFIRI plus aflibercept in metastatic colorectal cancer patients - AMALTHEA
Hellenic Cooperative Oncology Group0 个研究点目标入组 73 人开始时间: 2014年3月28日最近更新:
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
- 73
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. Signed and dated informed consent, and willing and able to comply with protocol requirements,
- •2. Histologically proven adenocarcinoma of the colon and/or rectum
- •3. Metastatic disease confirmed clinically/radiologically,
- •4. No prior therapy for metastatic disease
- •5. Duly documented inoperable metastatic disease, ie not suitable for complete curative surgical resection,
- •6. At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1
- •7. Age =18 years,
- •8. ECOG Performance status (PS) 0-2,
- •9. Adequate hematological status: neutrophils (ANC) =1.5x109/L; platelets =100x109/L; haemoglobin =9g/dL,
- •10. Adequate renal function: serum creatinine level =1.5 mg/dl and Glomelular Filtration Rate>50 ml/min by Cockroft/Gault formula,
- •11. Adequate liver function: serum bilirubin =1.5 x upper normal limit (ULN), alkaline phosphatase, AST, ALT <5xULN,
- •12. Proteinuria <2+ (dipstick urinalysis) or =1g/24hour,
- •13. Regular follow-up feasible,
- •14. Baseline evaluations performed before registration: clinical and blood evaluations no more than 2 weeks (14 days) prior to registration, tumor assessment (chest X ray, CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to registration,
- •15. First course of treatment planned less than 1 week (7 days) after registration,
- •16. For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior of starting study treatment,
- •17. 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.
- •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 51
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Exclusive presence of bone metastasis only,
- •2. Uncontrolled hypercalcemia,
- •3. Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg despite medical therapy), or history of hypertensive crisis, or hypertensive encephalopathy,
- •4. Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- •5. Treatment with any other investigational medicinal product within 28 days prior to study entry,
- •6. Other serious and uncontrolled chronic non-malignant disease,
- •7. History or presence of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizures not controlled with standard medical therapy)
- •8. Gilbert’s syndrome,
- •9. Intolerance to atropine sulfate or loperamide
- •10. Known dihydropyrimidine dehydrogenase deficiency
- •11. Treatment with CYP3A4 inducers unless discontinued > 7 days prior to randomization
- •12. 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.
- •13. Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
- •14. Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
- •15. Pregnant or breastfeeding women,
- •16. Patients with known allergy to any excipients to study drugs,
- •17. History of myocardial infarction and/or stroke or other arterial thrombotic events or pulmonary embolism or unstable angina pectoris within 6 months prior to registration,
- •18. Poorly controlled cardiac arrhythmias
- •19. Bowel obstruction
- •20. History of severe tumour bleeding or bleeding disorders
- •21. Poorly controlled anti-coagulation therapy (INR>3.0 on coumadin or heparin compounds)
- •22. Palliative radiation therapy within 4 weeks prior to registration.
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