EUCTR2007-005022-71-DE进行中（未招募）不适用
Prospective randomized Phase II trial with gemcitabine plus sunitinib versus gemcitabine alone in first-line therapy of metastatic or locally advanced pancreatic cancer
CESAR Central European Society for Anticancer Drug Research – EWIV0 个研究点目标入组 96 人开始时间: 2008年3月3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
- 96
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 who suffer from locally advanced or metastatic pancreatic cancer
- •(3)Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
- •(4)ECOG 0 or 1
- •(5)Signed written informed consent.
- •(6)White blood cell count (WBC) ? 3x10*9/L with neutrophils ? 1.5 x 10*9/L, platelet count ? 100x10*9/L, hemoglobin ? 5.6 mmol/L (9 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
- •(10)Anticoagulation treatment with heparin or low molecular weight heparin (LMWH): Patients will be allowed to participate provided that close monitoring of at least weekly evaluations are performed.
- •(11)Normal ECG without QT prolongation (QTc < 450 msec).
- •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
- •(12)Resectable pancreatic cancer
- •(13)Previous chemotherapy (for adjuvant or metastatic disease)
- •(14)Any contraindication for gemcitabine chemotherapy regimen.
- •(15)Any investigational drug within the 30 days before inclusion.
- •(16)Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
- •(17)Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
- •(18)Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
- •(19)Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception from the start of treatment up 6 months after end of treatment.
- •(20)Clinically symptomatic brain or meningeal metastasis. (known or suspected)
- •(21)Cardiac arrhythmias requiring anti-arhythmics (excluding beta blockers or digoxin).
- •(22)History of any of the following cardiac events within the past 6 months:
- •-myocardial infarction (including severe/unstable angina)
- •-coronary/peripheral artery bypass graft
- •-symptomatic congestive heart failure (CHF) > NYHA Class II
- •-cerebrovascular accident or transient ischemic attack
- •-pulmonary embolism
- •(23)uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ? 3 anti-hypertensive drugs
- •(24)Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
- •(25)Previous malignancy (other than pancreatic 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].
- •(26)History of organ allograft
- •(27)Significant disease which, in the investigator`s opinion would exclude the patient from the study.
- •(28)Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital)
- •(29)Patients requiring long-term cortisone therapy
- •(30)Patients requiring oral anticoagulation treatment (such as marcoumar)
- •(31)Legal incapacity or limited legal capacity
- •(32)Known alcohol or drug abuse.
- •(33)Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
- •(34)Current fistula formation.
研究者
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