EUCTR2011-005724-17-CZ进行中（未招募）1 期
A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 779
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
- •Histologically or cytologically proven adenocarcinoma of the colon or rectum
- •Metastatic disease
- •Eastern Cooperative Oncology Group performance status 0-1
- •One and only one prior chemotherapeutic regimen for metastatic disease. This
- •prior chemotherapy must be an oxaliplatin containing regimen. Patients must
- •have progressed during or after the oxaliplatin based chemotherapy. Patients
- •relapsed within 6 months of completion of oxaliplatin adjuvant chemotherapy are
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •Prior therapy with irinotecan
- •Inadequate bone marrow, liver and renal function: neutrophils < 1.5x109/L,
- •platelets < 100x109/L, hemoglobin < 9.0 g/dL, total bilirubin >1.5 x upper normal
- •limit (ULN), transaminases >3 x ULN (unless liver metastasis are present),
- •alkaline phosphatase >3 x ULN (unless liver metastasis are present), serum
- •creatinine > 1.5 x ULN.
- •Less than 4 weeks from prior radiotherapy, prior chemotherapy, prior major
- •surgery (or until the surgical wound is fully healed).
- •Treatment with any investigational drug within the prior 30 days.
- •Treatment with concomitant anticonvulsivant agents that are CYP3A4 inducers
- •(phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days.
- •History of brain metastases, uncontrolled spinal cord compression, or
- •carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
- •Prior malignancy (other than colorectal) including prior malignancy from which the
- •patient has been disease free for < 5 years (except adequately treated basal or
- •squamous cell skin cancer or carcinoma in situ of the cervix).
- •Any of the following within 6 months prior to study inclusion: myocardial infarction,
- •severe/unstable angina pectoris, coronary/peripheral artery bypass graft, severe
- •congestive heart failure, stroke or transient ischemic attack.
- •Any of the following within 3 months prior study inclusion: severe gastrointestinal
- •bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive
- •oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis,
- •pulmonary embolism or other uncontrolled thromboembolic event.
- •Occurrence of deep vein thrombosis within 4 weeks, prior to study inclusion.
- •Known dihydropyrimidine dehydrogenase deficiency.
- •Predisposing colonic or small bowel disorders in which the symptoms were
- •uncontrolled.
- •Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea,
- •unresolved bowel obstruction/sub-obstruction, more than hemicolectomy,
- •extensive small intestine resection with chronic diarrhea.
- •Known Gilbert’s syndrome.
- •Unresolved or unstable toxicity from any prior anti cancer therapy at the time of
- •History of anaphylaxis or known intolerance to atropine sulphate or loperamide or
- •appropriate antiemetics to be administered in conjunction with FOLFIRI
- •(irinotecan, 5-Fluorouracil, leucovorin).
- •Severe acute or chronic medical condition, which could impair the ability of the
- •patient to participate to the study.
- •Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria
- •> 500 mg/24-h.
- •Uncontrolled hypertension within 3 months prior to study inclusion.
- •Patients on anticoagulant therapy with unstable dose of warfarin and/or having an
- •out-of-therapeutic range INR within the 4 weeks prior to study inclusion.
- •Evidence of clinically significant bleeding predisposition or underlying
- •coagulopathy, non-healing wound.
- •Pregnant or breast-feeding women.
- •Patients with reproductive potential who do not agree to use an accepted
- •effective method of contraception.
研究者
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