EUCTR2013-000858-22-IT进行中（未招募）不适用
A Single-Arm, Open Label Study of Aflibercept as Maintenance Therapy Following Induction with Aflibercept in Combination with XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient - AMOR
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 not amenable to potentially curative treatment (i.e. unresectable).
- •- Measurable lesion as assessed by RECIST criteria
- •- No prior systemic anti-cancer treatment for metastatic disease
- •- No prior adjuvant treatment after resection of distant metastases
- •- No prior treatment with angiogenesis inhibitors
- •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 61
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •- Age <18 years
- •- Eastern Cooperative Oncology Group Performance status >/= 2
- •- Less than 4 weeks from prior radiotherapy or prior surgery (or until the surgical wound is fully healed)
- •- Treatment with any other investigational product within the prior 28 days
- •- Other prior neoplasm
- •- History of brain metastases, active seizure disorder, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
- •- Any of the following within the prior 6 months: 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 the prior 3 months: moderate/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
- •- Deep vein thrombosis within the prior 4 weeks
- •- Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study
- •- Inadequate bone marrow, liver and renal function: neutrophils < 1.5x10^9/L, platelets < 100x10^9/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
- •- Patients on anticoagulant therapy with warfarin.
- •- Symptomatic peripheral sensory neuropathy
- •- Inability to take oral medications
- •- Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, malabsorption syndrome, unresolved bowel obstruction/sub-obstruction, surgery more extensive than hemicolectomy, extensive small intestine resection with chronic diarrhea
- •- Known dihydropyrimidine dehydrogenase deficiency
- •- known history of hypersensitivity to aflibercept
- •- Any contraindication to administer oxaliplatin or capecitabine as per package insert of each drug
- •- Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria > 500 mg/24-h.
- •- Uncontrolled hypertension within the prior 3 months
- •- 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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