EUCTR2008-001515-37-DE进行中（未招募）不适用
A prospective angiogenic imaging study with DCE-MRI and DCE-USI in patients with colorectal cancer and liver metastases receiving sunitinib in addition to 5-FU, folinic acid and irinotecan (FOLFIRI) as 1st line therapy - Sunitinib in mCRC - Imaging
CESAR Central European Society for Anticancer Drug Research0 个研究点目标入组 22 人开始时间: 2008年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
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) Adult males and females: over 18 years of age.
- •(2) Patients with histologically or cytologically confirmed colorectal cancer who will receive their first palliative treatment.
- •(3) Patients who have at least one measurable hepatic lesion of 2 cm or more in the MRI evaluable according to RECIST criteria.
- •(4) ECOG 0 or 1.
- •(5) Signed written informed consent.
- •(6) White blood cell count (WBC) >= 4x10*9/L with neutrophils >= 1.5 x 10*9/L, platelet count >= 100x10*9/L, hemoglobin >= 5.6 mmol/L (10 g/dL).
- •(7) Total bilirubin =< 2 x upper limit of normal.
- •(8) AST and ALT =< 2.5 x upper limit of normal, or =< 5 x upper limit of normal in case of liver metastases.
- •(9) Serum creatinine =< 1.5 x upper limit of normal or creatinine clearance > 60 ml/min
- •(10)Normal ECG without QT prolongation.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(11)Resectable liver metastasis.
- •(12)Previous palliative chemotherapy (adjuvant therapy with FOLFOX or 5-FU / Capecitabine is allowed if end of adjuvant therapy >= 6 months prior to treatment on study.
- •(13)Any contraindication for FOLFIRI chemotherapy regimen.
- •(14)Any investigational drug within the 30 days before inclusion.
- •(15)Prior use of sunitinib or other multitarget tyrosine kinase inhibitors or VEGF pathway directed treatments like bevacizumab
- •(16)Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
- •(17)Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
- •(18)Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial
- •(19)Clinically symptomatic brain or meningeal metastasis. (known or suspected)
- •(20)Cardiac arrhythmias requiring anti-arhythmics (excluding beta blockers or digoxin).
- •(21)History of any of the following cardiac events within the past 6 months:
- •myocardial infarction (including severe/unstable angina)
- •coronary/peripheral artery bypass graft
- •congestive heart failure (CHF) cerebrovascular accident or transient ischemic attack pulmonary embolism.
- •(22)History of clinically significant bleeding within the past 6 months, including gross hemoptysis or haematuria, or underlying coagulopathy.
- •(23)History of peptic ulcer disease, deep vein thrombosis, or other significant thrombo-embolic event within the past 6 months.
- •(24)uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of >= 3 anti-hypertensive drugs
- •(25)Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
- •(26)Previous malignancy (other than colorectal cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor [Ta, Tis and T1].
- •(27)History of organ allograft
- •(28)Treatment with potent CYP3A4 inhibitor within 7 days of sunitinib/placebo dosing or with potent CYP3A4 inducer within 12 days of sunitinib/placebo dosing.
- •(29)Prior full field radiotherapy ? 4 weeks, or limited field radiotherapy, ? to 2 weeks prior to study enrollment; or previous radiation treatment >30% of the bone marrow.
- •(30)Major surgical procedure, open biopsy or significant traumatic injury within 4 weeks before starting treatment; anticipation of need for major surgical procedure (e.g., impending bowel obstruction) during the course of the study.
- •(31)History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment, unless affected area has been removed surgically.
- •(32)Significant disease which, in the investigator’s opinion would exclude the patient from the study.
- •(33)Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital)
- •(34)Patients requiring long-term cortisone therapy
- •(35)Patients requiring oral anticoagulation treatment (marcoumar)
- •(36)Known alcohol or drug abuse.
- •(37)Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
- •(38) Current fistula formation.
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